{
    "info": {
        "nct_id": "NCT04096391",
        "official_title": "Post-market, Randomized, Controlled, Prospective Study Evaluating Intrathecal Pain Medication (IT) Versus Conventional Medical Management (CMM) in the Non-cancer, Refractory, Chronic Pain Population (PROSPER)",
        "inclusion_criteria": "1. Subject must have signed and dated the IRB approved Informed Consent Form and HIPAA Authorization prior to any study procedures being performed\n2. Subject must be willing and able to complete study requirements including diaries, questionnaires and attend all visits, in the opinion of the investigator\n3. Subject must be male or female and at least 22 years of age\n4. Subjects who are female are non-lactating and if of childbearing potential have a negative urine pregnancy test at screening\n5. Subjects who are currently be receiving ≤ 90 mg/day morphine per day dose (or MME), with stable dose at equivalent of systemic opioids at Screening\n6. Subjects who are on a stable dose of opioids (no change in type or prescribed frequency or dose) for 30 days prior to the screening as documented in medical history;\n7. Subjects who have refractory pain despite failure of regional minimally invasive treatment options, including epidurals, facets, rhizotomies, direct or indirect spinal stenosis treatments, etc.\n8. Subjects who are a new candidate for chronic intrathecal drug therapy (including no prior intrathecal/epidural trial for pump infusion therapy)\n9. Subjects have not been implanted with a spinal cord stimulator for pain\n10. Subjects currently do not have an implanted spinal cord stimulator for pain\n11. Subjects who have a diagnosis of nonmalignant, chronic intractable pain as documented in the medical history\n12. Subjects who are medically stable and able to undergo surgery for implantation of the Prometra® II Infusion System\n13. Subject must have completed a psychological evaluation within 6 months prior to Screening\n14. Subject must complete an intrathecal trial resulting in candidacy for pump implantation during Screening\nHealthy volunteers allowed\nMust have minimum age of 22 Years",
        "exclusion_criteria": "A potential subject who has any contraindications listed in the Prometra® II labeling or any contraindications of intrathecal agents employed in the United States within the PACC, will be excluded. All subjects meeting any of the following criteria will also be excluded from this study:\n\n1. Subjects currently have a spinal cord stimulator implanted for pain\n2. Subjects previously had a spinal cord stimulator implanted for pain\n3. Subjects who have psychological or other health conditions, financial, and/or legal concerns (within 3 months prior to Screening) that would interfere with the subject's ability to fulfill the requirements of the protocol as per the investigator's opinion\n4. Subjects who have a history of alcohol abuse or illicit drug use within 2 years of screening\n5. Subjects who have an active malignancy or has been diagnosed with cancer and has not been in remission for at least 1 year prior to Screening\n6. Subjects who are female and who are pregnant, nursing or planning a pregnancy during the study or females of childbearing potential who are unable or unwilling to use a form of contraception during the study.\n7. Subjects who plan to enroll or is currently enrolled in another investigational drug or investigational medical device study or has participated in an investigational drug or medical device study within 30 days prior to Screening\n8. Subject has any condition or situation which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study\n\n   At the Baseline Visit or prior to Randomization, a subject will be excluded from continued participation if the subject has:\n9. Subjects that have a mean of the reported 12 hour \"average\" NPRS responses of < 6 on an eleven-point scale (0 to10) rated over the 5 days prior to the Baseline Visit (as recorded in the electronic Study Diary) in the absence of intolerable side effects as documented in the medical history\n10. Subjects with a negative urine test for opioids at Baseline\n11. Subjects with a positive Pregnancy test, if applicable\n12. Subjects that failed the intrathecal trial during Screening",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Subject must have signed and dated the IRB approved Informed Consent Form and HIPAA Authorization prior to any study procedures being performed",
            "criterions": [
                {
                    "exact_snippets": "Subject must have signed and dated the IRB approved Informed Consent Form",
                    "criterion": "Informed Consent Form",
                    "requirements": [
                        {
                            "requirement_type": "signed and dated",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HIPAA Authorization prior to any study procedures being performed",
                    "criterion": "HIPAA Authorization",
                    "requirements": [
                        {
                            "requirement_type": "signed and dated",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Subject must be willing and able to complete study requirements including diaries, questionnaires and attend all visits, in the opinion of the investigator",
            "criterions": [
                {
                    "exact_snippets": "Subject must be willing and able to complete study requirements",
                    "criterion": "willingness and ability to complete study requirements",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "including diaries",
                    "criterion": "completion of diaries",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "questionnaires",
                    "criterion": "completion of questionnaires",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "attend all visits",
                    "criterion": "attendance of all visits",
                    "requirements": [
                        {
                            "requirement_type": "attendance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Subject must be male or female and at least 22 years of age",
            "criterions": [
                {
                    "exact_snippets": "Subject must be male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 22 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 22,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Subjects who are female are non-lactating and if of childbearing potential have a negative urine pregnancy test at screening",
            "criterions": [
                {
                    "exact_snippets": "Subjects who are female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "non-lactating",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "if of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "negative urine pregnancy test at screening",
                    "criterion": "urine pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Subjects who are currently be receiving ≤ 90 mg/day morphine per day dose (or MME), with stable dose at equivalent of systemic opioids at Screening",
            "criterions": [
                {
                    "exact_snippets": "currently be receiving ≤ 90 mg/day morphine per day dose (or MME)",
                    "criterion": "morphine dose",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 90,
                                "unit": "mg/day"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "stable dose at equivalent of systemic opioids at Screening",
                    "criterion": "systemic opioid dose stability",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "stable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Subjects who are on a stable dose of opioids (no change in type or prescribed frequency or dose) for 30 days prior to the screening as documented in medical history;",
            "criterions": [
                {
                    "exact_snippets": "Subjects who are on a stable dose of opioids (no change in type or prescribed frequency or dose) for 30 days prior to the screening",
                    "criterion": "opioid use",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Subjects who have refractory pain despite failure of regional minimally invasive treatment options, including epidurals, facets, rhizotomies, direct or indirect spinal stenosis treatments, etc.",
            "criterions": [
                {
                    "exact_snippets": "refractory pain",
                    "criterion": "pain",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "refractory"
                        }
                    ]
                },
                {
                    "exact_snippets": "failure of regional minimally invasive treatment options, including epidurals, facets, rhizotomies, direct or indirect spinal stenosis treatments",
                    "criterion": "treatment options",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": "failure"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Subjects who are a new candidate for chronic intrathecal drug therapy (including no prior intrathecal/epidural trial for pump infusion therapy)",
            "criterions": [
                {
                    "exact_snippets": "new candidate for chronic intrathecal drug therapy",
                    "criterion": "candidate for chronic intrathecal drug therapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "new"
                        }
                    ]
                },
                {
                    "exact_snippets": "no prior intrathecal/epidural trial for pump infusion therapy",
                    "criterion": "prior intrathecal/epidural trial for pump infusion therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Subjects have not been implanted with a spinal cord stimulator for pain",
            "criterions": [
                {
                    "exact_snippets": "Subjects have not been implanted with a spinal cord stimulator for pain",
                    "criterion": "spinal cord stimulator implantation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Subjects currently do not have an implanted spinal cord stimulator for pain",
            "criterions": [
                {
                    "exact_snippets": "Subjects currently do not have an implanted spinal cord stimulator",
                    "criterion": "implanted spinal cord stimulator",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Subjects who have a diagnosis of nonmalignant, chronic intractable pain as documented in the medical history",
            "criterions": [
                {
                    "exact_snippets": "diagnosis of nonmalignant, chronic intractable pain",
                    "criterion": "nonmalignant chronic intractable pain",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "documented in the medical history",
                    "criterion": "documentation in medical history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Subjects who are medically stable and able to undergo surgery for implantation of the Prometra® II Infusion System",
            "criterions": [
                {
                    "exact_snippets": "medically stable",
                    "criterion": "medical stability",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "stable"
                        }
                    ]
                },
                {
                    "exact_snippets": "able to undergo surgery",
                    "criterion": "surgical eligibility",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Subject must have completed a psychological evaluation within 6 months prior to Screening",
            "criterions": [
                {
                    "exact_snippets": "Subject must have completed a psychological evaluation",
                    "criterion": "psychological evaluation",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 6 months prior to Screening",
                    "criterion": "psychological evaluation",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Subject must complete an intrathecal trial resulting in candidacy for pump implantation during Screening",
            "criterions": [
                {
                    "exact_snippets": "Subject must complete an intrathecal trial",
                    "criterion": "intrathecal trial completion",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "resulting in candidacy for pump implantation",
                    "criterion": "candidacy for pump implantation",
                    "requirements": [
                        {
                            "requirement_type": "candidacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 22 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 22 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 22,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "A potential subject who has any contraindications listed in the Prometra® II labeling or any contraindications of intrathecal agents employed in the United States within the PACC, will be excluded. All subjects meeting any of the following criteria will also be excluded from this study:",
            "criterions": [
                {
                    "exact_snippets": "contraindications listed in the Prometra® II labeling",
                    "criterion": "contraindications in Prometra® II labeling",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "contraindications of intrathecal agents employed in the United States",
                    "criterion": "contraindications of intrathecal agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Subjects currently have a spinal cord stimulator implanted for pain",
            "criterions": [
                {
                    "exact_snippets": "Subjects currently have a spinal cord stimulator implanted",
                    "criterion": "spinal cord stimulator",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Subjects previously had a spinal cord stimulator implanted for pain",
            "criterions": [
                {
                    "exact_snippets": "Subjects previously had a spinal cord stimulator implanted",
                    "criterion": "spinal cord stimulator implantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Subjects who have psychological or other health conditions, financial, and/or legal concerns (within 3 months prior to Screening) that would interfere with the subject's ability to fulfill the requirements of the protocol as per the investigator's opinion",
            "criterions": [
                {
                    "exact_snippets": "psychological or other health conditions",
                    "criterion": "psychological or other health conditions",
                    "requirements": [
                        {
                            "requirement_type": "interference with protocol",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "financial, and/or legal concerns (within 3 months prior to Screening)",
                    "criterion": "financial and/or legal concerns",
                    "requirements": [
                        {
                            "requirement_type": "interference with protocol",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Subjects who have a history of alcohol abuse or illicit drug use within 2 years of screening",
            "criterions": [
                {
                    "exact_snippets": "history of alcohol abuse",
                    "criterion": "alcohol abuse",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... illicit drug use",
                    "criterion": "illicit drug use",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Subjects who have an active malignancy or has been diagnosed with cancer and has not been in remission for at least 1 year prior to Screening",
            "criterions": [
                {
                    "exact_snippets": "Subjects who have an active malignancy",
                    "criterion": "active malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "diagnosed with cancer and has not been in remission for at least 1 year prior to Screening",
                    "criterion": "cancer remission",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Subjects who are female and who are pregnant, nursing or planning a pregnancy during the study or females of childbearing potential who are unable or unwilling to use a form of contraception during the study.",
            "criterions": [
                {
                    "exact_snippets": "Subjects who are female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "who are pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "pregnant"
                        }
                    ]
                },
                {
                    "exact_snippets": "nursing",
                    "criterion": "nursing status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "nursing"
                        }
                    ]
                },
                {
                    "exact_snippets": "planning a pregnancy during the study",
                    "criterion": "pregnancy planning",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "planning a pregnancy during the study"
                        }
                    ]
                },
                {
                    "exact_snippets": "females of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "of childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "unable or unwilling to use a form of contraception during the study",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "willingness and ability",
                            "expected_value": "unable or unwilling to use a form of contraception during the study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Subjects who plan to enroll or is currently enrolled in another investigational drug or investigational medical device study or has participated in an investigational drug or medical device study within 30 days prior to Screening",
            "criterions": [
                {
                    "exact_snippets": "Subjects who plan to enroll ... in another investigational drug or investigational medical device study",
                    "criterion": "enrollment in another investigational study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "is currently enrolled in another investigational drug or investigational medical device study",
                    "criterion": "current enrollment in another investigational study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "has participated in an investigational drug or medical device study within 30 days prior to Screening",
                    "criterion": "participation in investigational study within 30 days",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Subject has any condition or situation which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study",
            "criterions": [
                {
                    "exact_snippets": "any condition or situation which, in the investigator's opinion, puts the patient at significant risk",
                    "criterion": "condition or situation",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "any condition or situation which, in the investigator's opinion, ... could confound the study results",
                    "criterion": "condition or situation",
                    "requirements": [
                        {
                            "requirement_type": "confounding potential",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any condition or situation which, in the investigator's opinion, ... may interfere significantly with the subject's participation in the study",
                    "criterion": "condition or situation",
                    "requirements": [
                        {
                            "requirement_type": "interference with participation",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Subjects that have a mean of the reported 12 hour \"average\" NPRS responses of < 6 on an eleven-point scale (0 to10) rated over the 5 days prior to the Baseline Visit (as recorded in the electronic Study Diary) in the absence of intolerable side effects as documented in the medical history",
            "criterions": [
                {
                    "exact_snippets": "mean of the reported 12 hour \"average\" NPRS responses of < 6 on an eleven-point scale (0 to10) rated over the 5 days prior to the Baseline Visit",
                    "criterion": "NPRS responses",
                    "requirements": [
                        {
                            "requirement_type": "mean value",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "absence of intolerable side effects as documented in the medical history",
                    "criterion": "intolerable side effects",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Subjects with a negative urine test for opioids at Baseline",
            "criterions": [
                {
                    "exact_snippets": "negative urine test for opioids",
                    "criterion": "urine test for opioids",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Subjects with a positive Pregnancy test, if applicable",
            "criterions": [
                {
                    "exact_snippets": "positive Pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Subjects that failed the intrathecal trial during Screening",
            "criterions": [
                {
                    "exact_snippets": "failed the intrathecal trial during Screening",
                    "criterion": "intrathecal trial",
                    "requirements": [
                        {
                            "requirement_type": "outcome",
                            "expected_value": "failed"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "At the Baseline Visit or prior to Randomization, a subject will be excluded from continued participation if the subject has:",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}