{
    "info": {
        "nct_id": "NCT00365820",
        "official_title": "A Randomized, Double-blind, Placebo-controlled Multicenter Phase II/III Study to Evaluate the Efficacy and Safety of Tegaserod and Placebo Given Orally for 12 Weeks for the Treatment of Opioid-induced Constipation (OIC) in Patients With Chronic Non-cancer Pain",
        "inclusion_criteria": "1. Male and female outpatients 18 years of age or older.\n2. Patients with chronic non-cancer pain that necessitates the use of non-injectable opioid analgesics. The equivalent dose of 300 mg morphine per day is the maximum opioid analgesic dose allowed. In general, patients should be using opioids on a daily basis.\n3. Chronic pain which has been present for a minimum of 3 months which needs the chronic use of opioids for pain relief.\n4. Constipation, according to the investigator's clinical judgment, that is resulting from opioid use for non-cancer chronic pain. Opioid-induced constipation (OIC) is defined as follows:\n\n   * less than 3 spontaneous bowel movements per week and at least one of the following on at least 25% of occasions:\n\n     1. hard or very hard stools\n     2. sensation of incomplete evacuation\n     3. straining while having a bowel movement\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Patients who are receiving opioids for abdominal pain or connective tissue disorders.\n2. Planned discontinuation or an increase or decrease by more than 30% of the current opioid dose\n3. Patients who underwent major surgery within 3 months prior to screening.\n4. Patients with a history of prior chronic constipation (CC) that was present for more than three months and that was not related to opioid use.\n5. Patients with a current diagnosis of irritable bowel syndrome (IBS) constipation predominant or alternators.\n\nOther protocol-defined inclusion/exclusion criteria may apply.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Male and female outpatients 18 years of age or older.",
            "criterions": [
                {
                    "exact_snippets": "Male and female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "18 years of age or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients with chronic non-cancer pain that necessitates the use of non-injectable opioid analgesics. The equivalent dose of 300 mg morphine per day is the maximum opioid analgesic dose allowed. In general, patients should be using opioids on a daily basis.",
            "criterions": [
                {
                    "exact_snippets": "chronic non-cancer pain",
                    "criterion": "chronic non-cancer pain",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "necessitates the use of non-injectable opioid analgesics",
                    "criterion": "use of non-injectable opioid analgesics",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "The equivalent dose of 300 mg morphine per day is the maximum opioid analgesic dose allowed",
                    "criterion": "opioid analgesic dose",
                    "requirements": [
                        {
                            "requirement_type": "maximum dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 300,
                                "unit": "mg morphine per day"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients should be using opioids on a daily basis",
                    "criterion": "daily opioid use",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": "daily"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Chronic pain which has been present for a minimum of 3 months which needs the chronic use of opioids for pain relief.",
            "criterions": [
                {
                    "exact_snippets": "Chronic pain which has been present for a minimum of 3 months",
                    "criterion": "chronic pain",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic use of opioids for pain relief",
                    "criterion": "opioid use",
                    "requirements": [
                        {
                            "requirement_type": "chronic use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Constipation, according to the investigator's clinical judgment, that is resulting from opioid use for non-cancer chronic pain. Opioid-induced constipation (OIC) is defined as follows:",
            "criterions": [
                {
                    "exact_snippets": "Constipation, according to the investigator's clinical judgment, that is resulting from opioid use for non-cancer chronic pain.",
                    "criterion": "constipation",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "opioid use for non-cancer chronic pain"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* less than 3 spontaneous bowel movements per week and at least one of the following on at least 25% of occasions:",
            "criterions": [
                {
                    "exact_snippets": "less than 3 spontaneous bowel movements per week",
                    "criterion": "spontaneous bowel movements",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "per week"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. hard or very hard stools",
            "criterions": [
                {
                    "exact_snippets": "hard or very hard stools",
                    "criterion": "stool consistency",
                    "requirements": [
                        {
                            "requirement_type": "consistency",
                            "expected_value": [
                                "hard",
                                "very hard"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. sensation of incomplete evacuation",
            "criterions": [
                {
                    "exact_snippets": "sensation of incomplete evacuation",
                    "criterion": "sensation of incomplete evacuation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. straining while having a bowel movement",
            "criterions": [
                {
                    "exact_snippets": "straining while having a bowel movement",
                    "criterion": "straining during bowel movement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "1. Patients who are receiving opioids for abdominal pain or connective tissue disorders.",
            "criterions": [
                {
                    "exact_snippets": "Patients who are receiving opioids",
                    "criterion": "opioid use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "abdominal pain",
                    "criterion": "abdominal pain",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "connective tissue disorders",
                    "criterion": "connective tissue disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Planned discontinuation or an increase or decrease by more than 30% of the current opioid dose",
            "criterions": [
                {
                    "exact_snippets": "Planned discontinuation ... of the current opioid dose",
                    "criterion": "opioid dose",
                    "requirements": [
                        {
                            "requirement_type": "planned discontinuation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "increase ... by more than 30% of the current opioid dose",
                    "criterion": "opioid dose",
                    "requirements": [
                        {
                            "requirement_type": "change",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "decrease by more than 30% of the current opioid dose",
                    "criterion": "opioid dose",
                    "requirements": [
                        {
                            "requirement_type": "change",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients who underwent major surgery within 3 months prior to screening.",
            "criterions": [
                {
                    "exact_snippets": "underwent major surgery within 3 months prior to screening",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients with a history of prior chronic constipation (CC) that was present for more than three months and that was not related to opioid use.",
            "criterions": [
                {
                    "exact_snippets": "history of prior chronic constipation (CC)",
                    "criterion": "chronic constipation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "present for more than three months",
                    "criterion": "chronic constipation duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "not related to opioid use",
                    "criterion": "chronic constipation cause",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "not related to opioid use"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients with a current diagnosis of irritable bowel syndrome (IBS) constipation predominant or alternators.",
            "criterions": [
                {
                    "exact_snippets": "current diagnosis of irritable bowel syndrome (IBS)",
                    "criterion": "irritable bowel syndrome (IBS)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "constipation predominant or alternators",
                    "criterion": "IBS subtype",
                    "requirements": [
                        {
                            "requirement_type": "subtype",
                            "expected_value": [
                                "constipation predominant",
                                "alternators"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Other protocol-defined inclusion/exclusion criteria may apply.",
            "criterions": [
                {
                    "exact_snippets": "Other protocol-defined inclusion/exclusion criteria",
                    "criterion": "protocol-defined criteria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}