{
    "info": {
        "nct_id": "NCT00842829",
        "official_title": "A European Multicenter Open-Label Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients",
        "inclusion_criteria": "* The patient is willing to provide written informed consent to participate in this study.\n* The patient can be either an out-patient or an in-patient.\n* The patient has a histologically documented diagnosis of cancer.\n* The patient has stable background pain due to cancer.\n* The patient experiences up to 4 BTcP episodes per 24 hours.\n* As maintenance opioid therapy, the patient is currently taking 1 of the following: at least 60 mg of oral morphine/day, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone/day, at least 8 mg of hydromorphone/day, of an equianalgesic dose of another opioid for a week or longer before administration of the first dose of study drug.\n* Women of childbearing potential, using a medically accepted, highly effective method of birth control and agree to continued use of this method for the duration of the study.\n* The patient must be willing and able to successfully self-administer the study drug and to fill in study documents.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* The patient is without maintenance opioid therapy.\n* The patient has uncontrolled or rapidly escalating pain as determined by the investigator.\n* The patient has known or suspected hypersensitivities, allergies, or other contraindications to the active drug or to any of the excipients of the study drug.\n* The patient has respiratory depression or chronic obstructive pulmonary disease, or any other medical condition predisposing to respiratory depression.\n* The patient has medical or psychiatric disease that, in the opinion of the investigator, would compromise collected data.\n* The patient is expected to have surgery during the study.\n* The patient is pregnant or lactating.\n* The patient has participated in a study involving an investigational drug in the prior 30 days.\n* The patient has received a monoamine oxidase inhibitor (MAOI) within 14 days before the first treatment with study drug.\n* The patient has any other medical condition or is receiving concomitant medication/therapy (e.g., regional nerve block) that could, in the opinion of the investigator, compromise the patient's safety or compliance with the study protocol, or compromise collected data.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* The patient is willing to provide written informed consent to participate in this study.",
            "criterions": [
                {
                    "exact_snippets": "willing to provide written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient can be either an out-patient or an in-patient.",
            "criterions": [
                {
                    "exact_snippets": "The patient can be either an out-patient or an in-patient.",
                    "criterion": "patient status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "out-patient",
                                "in-patient"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient has a histologically documented diagnosis of cancer.",
            "criterions": [
                {
                    "exact_snippets": "histologically documented diagnosis of cancer",
                    "criterion": "cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": "histologically"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient has stable background pain due to cancer.",
            "criterions": [
                {
                    "exact_snippets": "stable background pain due to cancer",
                    "criterion": "background pain",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "stable"
                        },
                        {
                            "requirement_type": "cause",
                            "expected_value": "cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient experiences up to 4 BTcP episodes per 24 hours.",
            "criterions": [
                {
                    "exact_snippets": "up to 4 BTcP episodes per 24 hours",
                    "criterion": "BTcP episodes",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "episodes per 24 hours"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* As maintenance opioid therapy, the patient is currently taking 1 of the following: at least 60 mg of oral morphine/day, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone/day, at least 8 mg of hydromorphone/day, of an equianalgesic dose of another opioid for a week or longer before administration of the first dose of study drug.",
            "criterions": [
                {
                    "exact_snippets": "As maintenance opioid therapy, the patient is currently taking 1 of the following: at least 60 mg of oral morphine/day",
                    "criterion": "oral morphine",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mg/day"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "As maintenance opioid therapy, the patient is currently taking 1 of the following: ... at least 25 mcg of transdermal fentanyl/hour",
                    "criterion": "transdermal fentanyl",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 25,
                                "unit": "mcg/hour"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "As maintenance opioid therapy, the patient is currently taking 1 of the following: ... at least 30 mg of oxycodone/day",
                    "criterion": "oxycodone",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "mg/day"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "As maintenance opioid therapy, the patient is currently taking 1 of the following: ... at least 8 mg of hydromorphone/day",
                    "criterion": "hydromorphone",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8,
                                "unit": "mg/day"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "As maintenance opioid therapy, the patient is currently taking 1 of the following: ... of an equianalgesic dose of another opioid for a week or longer before administration of the first dose of study drug.",
                    "criterion": "equianalgesic dose of another opioid",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "a week or longer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of childbearing potential, using a medically accepted, highly effective method of birth control and agree to continued use of this method for the duration of the study.",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "using a medically accepted, highly effective method of birth control",
                    "criterion": "birth control method",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": "highly effective"
                        },
                        {
                            "requirement_type": "acceptance",
                            "expected_value": "medically accepted"
                        }
                    ]
                },
                {
                    "exact_snippets": "agree to continued use of this method for the duration of the study",
                    "criterion": "birth control method usage",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "for the duration of the study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient must be willing and able to successfully self-administer the study drug and to fill in study documents.",
            "criterions": [
                {
                    "exact_snippets": "willing and able to successfully self-administer the study drug",
                    "criterion": "self-administration of study drug",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing and able ... to fill in study documents",
                    "criterion": "completion of study documents",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "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 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* The patient is without maintenance opioid therapy.",
            "criterions": [
                {
                    "exact_snippets": "without maintenance opioid therapy",
                    "criterion": "maintenance opioid therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient has uncontrolled or rapidly escalating pain as determined by the investigator.",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled or rapidly escalating pain",
                    "criterion": "pain",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "uncontrolled",
                                "rapidly escalating"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient has known or suspected hypersensitivities, allergies, or other contraindications to the active drug or to any of the excipients of the study drug.",
            "criterions": [
                {
                    "exact_snippets": "known or suspected hypersensitivities, allergies, or other contraindications to the active drug",
                    "criterion": "hypersensitivities, allergies, or contraindications to the active drug",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known or suspected hypersensitivities, allergies, or other contraindications ... to any of the excipients of the study drug",
                    "criterion": "hypersensitivities, allergies, or contraindications to excipients of the study drug",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient has respiratory depression or chronic obstructive pulmonary disease, or any other medical condition predisposing to respiratory depression.",
            "criterions": [
                {
                    "exact_snippets": "The patient has respiratory depression",
                    "criterion": "respiratory depression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic obstructive pulmonary disease",
                    "criterion": "chronic obstructive pulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any other medical condition predisposing to respiratory depression",
                    "criterion": "medical condition predisposing to respiratory depression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient has medical or psychiatric disease that, in the opinion of the investigator, would compromise collected data.",
            "criterions": [
                {
                    "exact_snippets": "medical or psychiatric disease",
                    "criterion": "medical or psychiatric disease",
                    "requirements": [
                        {
                            "requirement_type": "impact on data",
                            "expected_value": "compromise collected data"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient is expected to have surgery during the study.",
            "criterions": [
                {
                    "exact_snippets": "The patient is expected to have surgery during the study.",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "during the study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient is pregnant or lactating.",
            "criterions": [
                {
                    "exact_snippets": "The patient is pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient has participated in a study involving an investigational drug in the prior 30 days.",
            "criterions": [
                {
                    "exact_snippets": "The patient has participated in a study involving an investigational drug in the prior 30 days.",
                    "criterion": "participation in a study involving an investigational drug",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient has received a monoamine oxidase inhibitor (MAOI) within 14 days before the first treatment with study drug.",
            "criterions": [
                {
                    "exact_snippets": "The patient has received a monoamine oxidase inhibitor (MAOI) within 14 days before the first treatment with study drug.",
                    "criterion": "monoamine oxidase inhibitor (MAOI)",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient has any other medical condition or is receiving concomitant medication/therapy (e.g., regional nerve block) that could, in the opinion of the investigator, compromise the patient's safety or compliance with the study protocol, or compromise collected data.",
            "criterions": [
                {
                    "exact_snippets": "The patient has any other medical condition",
                    "criterion": "other medical condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "is receiving concomitant medication/therapy",
                    "criterion": "concomitant medication/therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}