NCT00807326

A Comparison of Three Medications to Treat Diarrhea in Adults.

A Randomized, Parallel Group Comparison of Loperamide/Simeticone Caplet, Loperamide/Simeticone Chewable Tablet (IMODIUM® PLUS) and a Probiotic (Saccharomyces Boulardii) in the Treatment of Acute Diarrhea in Adults

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 415 (actual)
• Sponsor: McNeil AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A comparison of three medications to treat diarrhea in adults.

Detailed description

This single (investigator) blind, randomized, 3-arm, parallel-group study design was selected to show non-inferiority of loperamide/simeticone caplets compared to chewable tablets in a heterogeneous subject population aiming at validity of results and reducing bias. The study will also compare the loperamide/simeticone combinations versus a probiotic (Saccharomyces boulardii) in the treatment of acute diarrhea in adults. Probiotics have been used for acute infectious diarrhea to reduce the duration and severity of the illness.

Conditions

• Diarrhea

Interventions

Type	Name	Description
DRUG	Loperamide/simeticone 2 mg/125 mg caplets	Oral, 2 caplets taken initially at investigator site followed by one caplet after each unformed stool, maximum 4 caplets in a 24 hour period for a maximum of 48 hours (per product label)
DRUG	Loperamide/simeticone 2 mg/125 mg chewable tablets	Oral, 2 chewable tablets taken initially at the site followed by one chewable tablet after each unformed stool, maximum 4 chewable tablets in a 24 hour period for a maximum of 48 hours (per product label)
DRUG	Probiotic Saccharomyces boulardii 250 mg capsules	Oral, 1 capsule twice a day, maximum 2 capsules in a 24 hour period for a maximum of 5 days (per product label)

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-08-01
• Completion: 2009-11-01
• First posted: 2008-12-11
• Last updated: 2012-07-10

Locations

6 sites across 2 countries: India, Mexico