{
    "info": {
        "nct_id": "NCT00576173",
        "official_title": "An Open Label Study to Evaluate Safety, Tolerability and Clinical Utility of ULTRACET® (37.5mg Tramadol Hydrochloride/325mg Acetaminophen) for the Treatment of Breakthrough Pain in Cancer Patients",
        "inclusion_criteria": "* Patients with a histologically, radiologically or haematologically confirmed malignancy whose pain is judged by the investigator to be caused by the malignancy\n* Patients must have been on a stable daily dose of weak opioids or strong opioids for at least 72 hours prior to the start the study and must remain at the same dosage for the duration of the study\n* Patients must have a VAS (Visual analog scale) >=40mm\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients who have taken either morphine with daily dose more than 120mg or Fentanyl with daily dose more than 50ug/hr\n* Patients with significant abnormalities in hepatic or renal function which would, in the opinion of the investigator, prevent the patients involvement in the study\n* Patients with significant clinical abnormalities in CNS, respiratory or cardiovascular function, which in the investigators judgement prevents participation in the study\n* Patients who have taken antidepressants or anti-epileptic drugs, sedative hypnotics, selective serotonin reuptake inhibitor, short-acting analgesics, topical medications and anesthetics and/or muscle relaxants when taking Tramadol/Acetaminophen",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients with a histologically, radiologically or haematologically confirmed malignancy whose pain is judged by the investigator to be caused by the malignancy",
            "criterions": [
                {
                    "exact_snippets": [
                        "histologically, radiologically or haematologically confirmed malignancy"
                    ],
                    "criterion": "malignancy",
                    "requirement_type": "confirmation method",
                    "expected_value": [
                        "histologically",
                        "radiologically",
                        "haematologically"
                    ]
                },
                {
                    "exact_snippets": [
                        "pain is judged by the investigator to be caused by the malignancy"
                    ],
                    "criterion": "pain",
                    "requirement_type": "cause",
                    "expected_value": "malignancy"
                }
            ]
        },
        {
            "line": "* Patients must have been on a stable daily dose of weak opioids or strong opioids for at least 72 hours prior to the start the study and must remain at the same dosage for the duration of the study",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients must have been on a stable daily dose of weak opioids or strong opioids"
                    ],
                    "criterion": "opioid use",
                    "requirement_type": "stability",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "at least 72 hours prior to the start the study"
                    ],
                    "criterion": "opioid use",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 72
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "must remain at the same dosage for the duration of the study"
                    ],
                    "criterion": "opioid dosage",
                    "requirement_type": "stability",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Patients must have a VAS (Visual analog scale) >=40mm",
            "criterions": [
                {
                    "exact_snippets": [
                        "VAS (Visual analog scale) >=40mm"
                    ],
                    "criterion": "VAS (Visual analog scale)",
                    "requirement_type": "value",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 40
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients who have taken either morphine with daily dose more than 120mg or Fentanyl with daily dose more than 50ug/hr",
            "criterions": [
                {
                    "exact_snippets": [
                        "morphine",
                        "daily dose more than 120mg"
                    ],
                    "criterion": "morphine",
                    "requirement_type": "daily dose",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 120
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Fentanyl",
                        "daily dose more than 50ug/hr"
                    ],
                    "criterion": "Fentanyl",
                    "requirement_type": "daily dose",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 50
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Patients with significant clinical abnormalities in CNS, respiratory or cardiovascular function, which in the investigators judgement prevents participation in the study",
            "criterions": [
                {
                    "exact_snippets": [
                        "significant clinical abnormalities in CNS"
                    ],
                    "criterion": "CNS function",
                    "requirement_type": "abnormality",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "significant clinical abnormalities in",
                        "respiratory"
                    ],
                    "criterion": "respiratory function",
                    "requirement_type": "abnormality",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "significant clinical abnormalities in",
                        "cardiovascular"
                    ],
                    "criterion": "cardiovascular function",
                    "requirement_type": "abnormality",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Patients who have taken antidepressants or anti-epileptic drugs, sedative hypnotics, selective serotonin reuptake inhibitor, short-acting analgesics, topical medications and anesthetics and/or muscle relaxants when taking Tramadol/Acetaminophen",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients who have taken antidepressants"
                    ],
                    "criterion": "antidepressants",
                    "requirement_type": "prior use",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Patients who have taken",
                        "anti-epileptic drugs"
                    ],
                    "criterion": "anti-epileptic drugs",
                    "requirement_type": "prior use",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Patients who have taken",
                        "sedative hypnotics"
                    ],
                    "criterion": "sedative hypnotics",
                    "requirement_type": "prior use",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Patients who have taken",
                        "selective serotonin reuptake inhibitor"
                    ],
                    "criterion": "selective serotonin reuptake inhibitor",
                    "requirement_type": "prior use",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Patients who have taken",
                        "short-acting analgesics"
                    ],
                    "criterion": "short-acting analgesics",
                    "requirement_type": "prior use",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Patients who have taken",
                        "topical medications"
                    ],
                    "criterion": "topical medications",
                    "requirement_type": "prior use",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Patients who have taken",
                        "anesthetics"
                    ],
                    "criterion": "anesthetics",
                    "requirement_type": "prior use",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Patients who have taken",
                        "muscle relaxants"
                    ],
                    "criterion": "muscle relaxants",
                    "requirement_type": "prior use",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "when taking Tramadol/Acetaminophen"
                    ],
                    "criterion": "Tramadol/Acetaminophen",
                    "requirement_type": "concurrent use",
                    "expected_value": true
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Patients with significant abnormalities in hepatic or renal function which would, in the opinion of the investigator, prevent the patients involvement in the study",
            "criterions": [
                {
                    "exact_snippets": [
                        "significant abnormalities in hepatic",
                        "prevent the patients involvement"
                    ],
                    "criterion": "hepatic function",
                    "requirement_type": "abnormality",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "significant abnormalities in renal",
                        "prevent the patients involvement"
                    ],
                    "criterion": "renal function",
                    "requirement_type": "abnormality",
                    "expected_value": true
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}