Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT00277550
Status:
WITHDRAWN
Last Update Posted:
2016-03-04
First Post:
2006-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Tegaserod vs. Placebo on Whole Gut Transit Time in Patients With Chronic Constipation and Dyspepsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'statusVerifiedDate': '2016-03', 'lastUpdateSubmitDate': '2016-03-02', 'studyFirstSubmitDate': '2006-01-13', 'studyFirstSubmitQcDate': '2006-01-13', 'lastUpdatePostDateStruct': {'date': '2016-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the effect of one week of tegaserod on the passage of content through the gut by radiological procedures.'}], 'secondaryOutcomes': [{'measure': 'To evaluate the PD effects of tegaserod on upper & lower GI transit'}, {'measure': 'To evaluate global well-being & upper and lower GI symptoms in daily assessment of bowel habits and weekly global and individual symptom assessments'}]}, 'conditionsModule': {'keywords': ['Constipation, Tegaserod, Dyspepsia'], 'conditions': ['Constipation and Dyspepsia']}, 'descriptionModule': {'briefSummary': 'To demonstrate the effects of tegaserod on gastrointestinal scintigraphic orocecal transit in female patients with CC and upper GI symptoms of dyspepsia'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females aged 18 to 64 years of age\n* Patients must present with two or more of the following criteria for chronic constipation for at least 12 weeks prior to entering the study:\n\n 1. Less than 3 bowel movements per week\n 2. Hard or lumpy stools\n 3. Straining during bowel movements\n 4. Feeling of incomplete evacuation\n* Patients must report overlapping symptoms consistent with dyspepsia, such as mid-upper abdominal discomfort characterized by early satiety, post-meal fullness and bloating\n\nExclusion Criteria:\n\n* Patients with a recent history of, or current frequency of diarrhea occuring more than once per month off of laxatives\n* Clinically significant diagnosis of pelvic outlet obstruction or pelvic floor dyssenergia as determined by the study physicians\n* Patients with constipation secondary to medication use as determined by the study physician\n* Patients with clinically significant abnormal TSH levels at screening\n* Patients that have heartburn or abdominal pain as their predominant GI symptom\n* Evidence of cathartic colon or a history of laxative abuse\n\n * Other protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00277550', 'briefTitle': 'The Effects of Tegaserod vs. Placebo on Whole Gut Transit Time in Patients With Chronic Constipation and Dyspepsia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Evaluation of the Effects of Tegaserod (6 mg b.i.d) on Whole Gut Transit Time in Patients With Chronic Idiopathic Constipation and Dyspepsia', 'orgStudyIdInfo': {'id': 'CHTF919EUS42'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tegaserod and Placebo', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nicholas Talley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}, {'name': 'Michael Crowell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Mayo Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}