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Clinical Trial Summary

A comparison of three medications to treat diarrhea in adults.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00807326
Study type Interventional
Source Johnson & Johnson Consumer and Personal Products Worldwide
Contact
Status Completed
Phase Phase 4
Start date November 2008
Completion date November 2009

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