Efficacy of Tegaserod in Relieving the Symptoms of Female Patients With Irritable Bowel Syndrome (IBS), Excluding Those With Predominant Diarrhea IBS
- Conditions
- -K58K58
- Registration Number
- PER-014-04
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Criteria of constipation and diarrhea Rome II<br>Measure:Weekly evaluation of relief of general patient satisfaction during 4 weeks of treatment of symptoms of irritable bowel syndrome.<br>Timepoints:4 weeks<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Monitoring and recording of all adverse events and all serious adverse events, in the periodic monitoring of vital signs and in the performance of physical examinations.<br>Measure:Evaluation of safety and tolerability.<br>Timepoints:4 weeks<br>