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

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00142987
• Collaborator: (none)
• Enrollment: 664
• Duration (Months): 14

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
IBS-C and IBS With Mixed Bowel Habits	Drug: Tegaserod	Phase 4

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Efficacy of Tegaserod in Relieving the Symptoms of Female Patients With Irritable Bowel Syndrome (IBS), Excluding Those With Predominant Diarrhea IBS
• Study Start Date: Apr 1, 2004
• Actual Study Completion Date: Jun 1, 2005

Outcome Measures

Primary Outcome Measures

1. Weekly assessment of patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms []

Secondary Outcome Measures

1. Weekly assessment of patient's overall satisfaction relief. []

2. Over 4 weeks of treatment and during each week improvment of abdominal discomfort pain, bloating, stool frequency, stool consitency, straining urgency. []

3. During 4 week treatment period efficacy assessment in IBS-C subgroup and mixed IBS. []

4. Assessment of safety and tolerability. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Novartis

Investigators

• Study Chair: Novartis, East Hanover NJ

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00142987
• Other Study ID Numbers: CHTF919A2417
• First Posted: Sep 2, 2005
• Last Update Posted: Jan 28, 2008
• Last Verified: Jan 1, 2008

• Keywords provided by , ,: Tegaserod, IBS-C, women, mixed bowel habit
• Additional relevant MeSH terms: Irritable Bowel Syndrome; Diarrhea; Tegaserod

Study Results

No Results Posted as of Jan 28, 2008