Overview

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

Status:
Completed
Trial end date:
2005-06-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 4
Details
Lead Sponsor:
Novartis
Treatments:
Tegaserod
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

Other protocol-defined inclusion/exclusion criteria may apply.