Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2025-12-27 @ 6:43 PM
Study NCT ID:
NCT00139568
Status:
COMPLETED
Last Update Posted:
2008-02-01
First Post:
2005-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Evaluation of the Efficacy and Safety of Tegaserod 6 mg Bid Given Orally to Chinese Patients With Chronic Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C105050', 'term': 'tegaserod'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-31', 'studyFirstSubmitDate': '2005-08-30', 'studyFirstSubmitQcDate': '2005-08-30', 'lastUpdatePostDateStruct': {'date': '2008-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in number of complete spontaneous bowel movements (CSBM) per week'}], 'secondaryOutcomes': [{'measure': 'Response rate for CSBM during the first 4 weeks of treatment'}, {'measure': "Patients' daily assessment of bowel habits"}, {'measure': "Patients' weekly assessment of constipation symptoms"}, {'measure': 'Satisfactory relief of CC symptoms'}, {'measure': 'PAC-QoL questionnaire'}, {'measure': 'PPSM questionnaire'}, {'measure': 'Safety'}]}, 'conditionsModule': {'keywords': ['Chronic constipation', '5-HT,5-HT4,', 'functional GI', 'China', 'tegaserod'], 'conditions': ['Constipation']}, 'descriptionModule': {'briefSummary': 'Tegaserod is an aminoguanidine indole compound and a member of a new class of 5-hydroxytryptamine (5-HT) agonists. Activation of 5-HT4 receptors triggers the release of neurotransmitters from the enteric nerves which in turn stimulate contractility and peristalsis. This study will investigate the efficacy and safety of tegaserod against chronic constipation in a Chinese population of adult men and women'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women at least 18 years of age\n* History of constipation for at least 6 months prior to screening\n* Normal bowel evaluation performed within the past 5 years\n\nExclusion Criteria:\n\n* Most bothersome symptom in last 6 months is abdominal pain/discomfort\n* Whose chronic constipation is thought to be a result of bowel surgery, gynecological surgery, neurologic disorder, systemic sclerosis, amyloidosis, scleroderma, myotonic dystrophy\n* Insulin dependent diabetes\n* Evidence of cathartic colon or laxative abuse\n\nOther inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00139568', 'briefTitle': 'An Evaluation of the Efficacy and Safety of Tegaserod 6 mg Bid Given Orally to Chinese Patients With Chronic Constipation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'An Evaluation of the Efficacy and Safety of Tegaserod 6 mg Bid Given Orally to Chinese Patients With Chronic Constipation', 'orgStudyIdInfo': {'id': 'CHTF919E2308'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tegaserod', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4056', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Novartis', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Novartis', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis Basel, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}}}}