Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT00365820
Status:
TERMINATED
Last Update Posted:
2012-04-20
First Post:
2006-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}, {'id': 'D000079689', 'term': 'Opioid-Induced Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C105050', 'term': 'tegaserod'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 670}}, 'statusModule': {'whyStopped': 'This study was terminated early as a result of regulatory action suspending tegaserod use in 2007', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-19', 'studyFirstSubmitDate': '2006-08-17', 'studyFirstSubmitQcDate': '2006-08-17', 'lastUpdatePostDateStruct': {'date': '2012-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in the number of bowel movements over weeks 1-4'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in the number of bowel movements over weeks 1-12'}, {'measure': 'Change from baseline in abdominal distension/bloating over weeks 1-12'}, {'measure': 'Change from baseline in abdominal discomfort/pain over weeks 1-12'}]}, 'conditionsModule': {'keywords': ['Opioid, constipation, tegaserod', 'Opioid-induced constipation'], 'conditions': ['Constipation']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of tegaserod in opioid-induced constipation in patients with non-cancer pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 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\n\nExclusion Criteria:\n\n1. 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."}, 'identificationModule': {'nctId': 'NCT00365820', 'briefTitle': 'Efficacy and Safety of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CHTF919N2201'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tegaserod', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 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