Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-01-04 @ 5:44 PM
Study NCT ID:
NCT00399659
Status:
TERMINATED
Last Update Posted:
2012-05-01
First Post:
2006-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy 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': 'D000079689', 'term': 'Opioid-Induced Constipation'}, {'id': 'D003248', 'term': '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 360}}, 'statusModule': {'whyStopped': 'This study was terminated early as a result of regulatory action suspending tegaserod use in 2007', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-11'}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-30', 'studyFirstSubmitDate': '2006-11-14', 'studyFirstSubmitQcDate': '2006-11-14', 'lastUpdatePostDateStruct': {'date': '2012-05-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long term safety of tegaserod'}], 'secondaryOutcomes': [{'measure': 'Change from baseline assessment of OIC symptoms, at week 24 and 52'}, {'measure': 'Change from baseline assessment of opioid-induced mid/upper GI symptoms, at week 24 and 52'}, {'measure': "Patients' weekly assessment of intensity of pain for which opioids were prescribed, at week 24 and 52"}]}, 'conditionsModule': {'keywords': ['Opioid, constipation, tegaserod'], 'conditions': ['Opioid-induced Constipation']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of Tegaserod in opioid-induced constipation (OIC) in patients with non-cancer pain.\n\nPatients who enter this study PRIOR to the core study (CHTF919N2201) interim analysis (IA) receive the treatment as follows:\n\nPatients on tegaserod 6 mg twice daily (b.i.d.) or 12 mg once daily (o.d.) in the core study will remain on the same dose in the extension (double-blind).\n\nPatients on placebo during the core study will receive tegaserod 12 mg o.d. (open-label)\n\nPatients who enter this study AFTER the core study interim analysis will receive the selected tegaserod dose regimen (open-label) determined by the core study IA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has completed the 12 week double blind treatment of study CHTF919N2201\n\nExclusion Criteria:\n\n* Planned discontinuation of opioids during the study.\n* Development of any of the medical conditions listed as exclusion criteria for the CHTF919N2201 study.\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00399659', 'briefTitle': 'Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 52-week Extension to Study CHTF919N2201 to Evaluate the Safety and Efficacy of Tegaserod (6 mg b.i.d. and 12 mg o.d.) Given Orally for the Treatment of Opioid-induced Constipation (OIC) in Patients With Chronic Non-cancer Pain', 'orgStudyIdInfo': {'id': 'CHTF919N2201E1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tegaserod', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85029', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85050', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72117', 'city': 'North Little 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{'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals Corp.', 'role': 'STUDY_CHAIR', 'affiliation': 'NPC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}