Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-27 @ 11:16 PM
Study NCT ID:
NCT00348634
Status:
TERMINATED
Last Update Posted:
2016-03-04
First Post:
2006-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Tegaserod on Orocecal Transit in Elderly Chronic Constipation Patients
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'whyStopped': 'Terminated early due to regulatory action suspending tegaserod use in 2007', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-07'}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-02', 'studyFirstSubmitDate': '2006-07-03', 'studyFirstSubmitQcDate': '2006-07-03', 'lastUpdatePostDateStruct': {'date': '2016-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Orocecal transit: Time of radioactive marker to reach the cecum using scintigraphy'}], 'secondaryOutcomes': [{'measure': 'Whole gut transit and stomach emptying: Following 2 weeks of treatment, the rate of transit of food through the colon and stomach will be measured using scintigraphy'}]}, 'conditionsModule': {'keywords': ['Constipation, Tegaserod, orocecal transit, colonic transit, gastric emptying'], 'conditions': ['Chronic Constipation']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effects of tegaserod on orocecal and colonic transit in patients over 65 years with chronic constipation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male \\& Females aged 65 and older\n* Patients must meet the criteria for chronic idiopathic constipation for at least 12 weeks\n* Patients must have had a colonoscopy within the past 5 years\n* Patients must pass a balloon expulsion test at screening\n* Patients must be able to comply and understand the use of a diary\n\nExclusion Criteria:\n\n* Patients with a clinically significant medical condition that would interfere with the patient completing the trial\n* Patients with loose stools at least once per week\n* Patients with IBS\n* Known allergies to the same class of drug and/or allergies to eggs\n* Patients who require the use of manual maneuvers to have a bowel movement\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00348634', 'briefTitle': 'Effect of Tegaserod on Orocecal Transit in Elderly Chronic Constipation Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'The Effects of Tegaserod on Orocecal Transit in Elderly Patients With Chronic Constipation', 'orgStudyIdInfo': {'id': 'CHTF919EUS51'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tegaserod', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72117', 'city': 'North Little Rock', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arkansas Gastroenterology, PA'}, {'zip': '48109-0362', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Medical Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Henry Parkman, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Temple'}, {'name': 'William Chey, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Temple University', 'class': 'OTHER'}, {'name': 'University of Michigan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}