DOUBLE-BLIND, PLACEBO CONTROLLED, RANDOMIZED, MULTICENTRIC STUDY TO EVALUATE THE SECURITY AND EFFICACY OF 2 MG 3 TIMES PER DAY OF CILANSETRON FOR 12 WEEKS, FOLLOWED BY A RANDOMIZED 4-WEEK TREATMENT PERIOD IN SUBJECTS WITH IRRITABLE COLON SYNDROME WITH PREDOMINANCE DIARRHEAL.
Phase 1
- Conditions
- -K580 Irritable bowel syndrome with diarrhoeaIrritable bowel syndrome with diarrhoeaK580
- Registration Number
- PER-004-03
- Lead Sponsor
- SOLVAY PHARMACEUTICALS,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients with SCI who meet the 1992 Rome Criteria of SCI; the subpopulation with predominance of diarrhea is defined according to criteria II of Rome; The minimum frequency and consistency of bowel movements and abdominal pain during the pre-randomization period will be determined.
Exclusion Criteria
Evidence of severe cardiovascular, respiratory, urogenital, gastrointestinal / hepatic, hematological / immunological disease.
Women who are pregnant or nursing.
History of drug or alcohol abuse.
Treatment with any investigational drug within four weeks
prior to inclusion in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Irritable bowel syndrome symptoms responders index according to a weekly evaluation of adequate relief of symptoms.<br>Measure:Efficacy and establish the superiority of cilansetron with respect to placebo, administered for 12 weeks in subjects with irritable bowel syndrome with predominance of diarrhea.<br>Timepoints:30 days<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Irritable bowel syndrome symptoms responders index according to a weekly evaluation of pain relief and abdominal discomfort.<br>Measure:Index of responders based on the weekly question on adequate pain relief, abdominal discomfort.<br>Timepoints:30 days<br>