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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.

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.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
REPEC
Registry ID
PER-004-03
Enrollment
66
Registered
2003-02-19
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Cilansetron 2 mg Type of group
Cilansetron 2 mg will be given 3 times a day in subjects with irritable bowel syndrome with diarrhea predominance during a 12-week treatment period, followed by a re-randomized, double-blind, placebo-controlled treatment period of 4 weeks (total of 16 weeks). Group name:placebo Type of group
Cilansetron 2 mg placebo will be administered 3 times a day in subjects with irritable bowel syndrome with predominance of diarrhea during a 12-week treatment period, followed by a re-randomized, double-blind, placebo-controlled treatment period of 4 weeks of duration (16 weeks in total).

Sponsors

SOLVAY PHARMACEUTICALS,
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Outcome name:Irritable bowel syndrome symptoms responders index according to a weekly evaluation of adequate relief of symptoms. 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. Timepoints:30 days—

Secondary

MeasureTime frame
Outcome name:Irritable bowel syndrome symptoms responders index according to a weekly evaluation of pain relief and abdominal discomfort. Measure:Index of responders based on the weekly question on adequate pain relief, abdominal discomfort. Timepoints:30 days—

Countries

Argentina, Brazil, Chile, Colombia, Peru, United States

Outcome results

None listed

Source: REPEC (via WHO ICTRP)