Status:
COMPLETED
Efficacy of Tegaserod in Relieving the Symptoms of Female Patients With Irritable Bowel Syndrome (IBS), Excluding Those With Predominant Diarrhea IBS
Lead Sponsor:
Novartis
Conditions:
IBS-C and IBS With Mixed Bowel Habits
Eligibility:
FEMALE
18-65 years
Phase:
PHASE4
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 an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
664 Patients enrolled
Trial Details
Trial ID
NCT00142987
Start Date
April 1 2004
End Date
June 1 2005
Last Update
January 28 2008
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