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

Phase 4

Completed

• Conditions: IBS-C and IBS With Mixed Bowel Habits

• Registration Number: NCT00142987
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study Completion: 2005-06
• Study First Submitted: 2005-08-31
• Study First Submitted QC: 2005-08-31
• Study First Posted: 2005-09-02
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-24
• Last Update Posted: 2008-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 664

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

Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Weekly assessment of patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms

Secondary Outcome Measures

Name	Time	Method
Weekly assessment of patient's overall satisfaction relief.
Over 4 weeks of treatment and during each week improvment of abdominal discomfort pain, bloating, stool frequency, stool consitency, straining urgency.
During 4 week treatment period efficacy assessment in IBS-C subgroup and mixed IBS.
Assessment of safety and tolerability.