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

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.

Study Overview

• Status: Completed
• Conditions: IBS-C and IBS With Mixed Bowel Habits
• Intervention / Treatment: Drug: Tegaserod

• Study Type: Interventional
• Enrollment: 664
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Weekly assessment of patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: Novartis
• Investigators: Study Chair: Novartis, East Hanover NJ

Study record dates

Study Major Dates

• Study Start: April 1, 2004
• Study Completion (Actual): June 1, 2005

Study Registration Dates

• First Submitted: August 31, 2005
• First Submitted That Met QC Criteria: August 31, 2005
• First Posted (Estimate): September 2, 2005

Study Record Updates

• Last Update Posted (Estimate): January 28, 2008
• Last Update Submitted That Met QC Criteria: January 24, 2008
• Last Verified: January 1, 2008

More Information

Terms related to this study

• Keywords: Tegaserod, IBS-C, women, mixed bowel habit
• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome; Diarrhea; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin Receptor Agonists; Tegaserod
• Other Study ID Numbers: CHTF919A2417