RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY, IN PARALLEL GROUPS, MULTICENTER, TO EVALUATE EFFICACY AND SAFETY IN TREATMENT REPEATED WITH TEGASEROD 6 MG TWICE PER DAY AND PLACEBO IN WOMEN WITH IRRITABLE BOWEL SYNDROME CO
Not Applicable
- Conditions
- -K559 Vascular disorder of intestine, unspecifiedVascular disorder of intestine, unspecifiedK559
- Registration Number
- PER-076-02
- 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
Inclusion Criteria
Women, 18 - 65 years old.
patients presenting at least 12 weeks or more (not necessarily consecutive) in the preceding 12 months, with discomfort or abdominal pain that presents two of the following three characteristics: 1) relief with the deposition and / or 2) onset associated with a change in stool frequency and / or 3) onset associated with a change in the shape (appearance) of the stool.
Exclusion Criteria
Significant diarrhea (2 or more of the Rome criteria, Section D) associated with IBS-C at least 25% of the time during the last three months.
Evidence of structural abnormality of the gastrointestinal tract or
diseases / disorders that affect intestinal transit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method