Efficacy of Tegaserod in Relieving the Symptoms of Female Patients With Irritable Bowel Syndrome (IBS), Excluding Those With Predominant Diarrhea IBS

NCT ID: NCT00142987

Last Updated: 2008-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 664 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2005-06-30

Brief Summary

Recent literature has demonstrated that the group of IBS sufferers who experience mixed bowel habits may be more similar to IBS-C patients than IBS-D patients. This study will evaluate the efficacy and safety of tegaserod 6 mg b.i.d. in women with IBS and mixed bowel habits, excluding those with predominant diarrhea.

Conditions

IBS-C and IBS With Mixed Bowel Habits

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Tegaserod

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• women, outpatients, 18-65 years of age with IBS-C or IBS with mixed bowel habits
• In the 12 months preceding study entry, they had to have at least 12 weeks (not necessarily consecutive) of abdominal discomfort/pain with 2 out of 3 features: 1) relieved with defecation; 2) onset associated with a change in stool frequency; 3) onset associated with a change in form (appearance) of stool.
• Had to fulfill the following criteria (IBS questionnaire) during the last 3 months prior to study entry: abdominal discomfort or pain present during at least 3 weeks in the last 3 months, and at least two of the following: abdominal discomfort or pain gets better or stops after a bowel movement; change in bowel movement frequency when the abdominal discomfort or pain starts; change in bowel movement consistency when the abdominal discomfort or pain starts

Exclusion Criteria

• IBS-D
• not reporting any constipation and diarrhea criteria
• evidence of structural abnormality of the gastrointestinal tract or diseases/conditions that affect bowel transit
• history of bowel obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or abdominal adhesions
• evidence of cathartic colon or history of laxative abuse

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Principal Investigators

Novartis

Role: STUDY_CHAIR

East Hanover NJ

Other Identifiers

CHTF919A2417

Identifier Type: -

Identifier Source: org_study_id