Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT00232102
Status:
COMPLETED
Last Update Posted:
2008-02-01
First Post:
2005-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004415', 'term': 'Dyspepsia'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C105050', 'term': 'tegaserod'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 423}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-31', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-10-03', 'lastUpdatePostDateStruct': {'date': '2008-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long term safety at 6 months.'}], 'secondaryOutcomes': [{'measure': 'Long term safety at 1 year.'}, {'measure': 'Quality of life : Nepean Dyspepsia Index, WPAI, patient perception of study medication-dyspepsia questionnaire.'}, {'measure': 'Efficacy on satisfactory relief at month 6 and 12.'}]}, 'conditionsModule': {'keywords': ['Dyspepsia, gastrointestinal, tegaserod'], 'conditions': ['Dyspepsia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.novartisclinicaltrials.com/etrials/DiseaseID21/Dyspepsia-clinical-trials.go', 'label': 'Click here for more information about this study: Clinical trial of dyspepsia in females'}]}, 'descriptionModule': {'briefSummary': 'This study is being done to evaluate the long-term safety of tegaserod in women with symptoms of dyspepsia who have completed the core study. Tegaserod will be evaluated at 6 mg twice daily.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female, 18 years and older\n* Fulfilled eligibility criteria in CHTF919 D2302 (double blind study) and successfully completed the double-blind study\n\nExclusion Criteria:\n\n\\- Early discontinuation from the double-blind study\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00232102', 'briefTitle': 'Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia', 'orgStudyIdInfo': {'id': 'CHTF919D2302E1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tegaserod', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07936-108', 'city': 'East Hanover', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novartis', 'geoPoint': {'lat': 40.8201, 'lon': -74.36487}}], 'overallOfficials': [{'name': 'Novartis', 'role': 'STUDY_CHAIR', 'affiliation': 'East Hanover NJ'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}}}}