NCT00685607

Study to Determine the Best Way to Measure How Quickly the Drug Can Give Relief From Sudden Diarrhea

A Placebo-Controlled, Double-Blind, Randomized Pilot Study to Evaluate the Appropriateness of Multiple Endpoints in Measuring the Onset of Clinical Efficacy of Loperamide-Simethicone Caplets in the Treatment of Acute Non-specific Diarrhea

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

For six hours following drug administration, subjects will rate the severity of specific symptoms. At the end of the six hour study, subjects will rate the overall effectiveness of the product.

Detailed description

A six-hour study to evaluate multiple early efficacy endpoints in loperamide-simethicone therapy to help identify speed of onset of symptomatic treatment of acute nonspecific diarrhea (ANSD).

Conditions

• Diarrhea

Interventions

Type	Name	Description
DRUG	loperamide-simethicone	Four caplets containing 2 mg loperamide HCl and 125 mg of simethicone each, administered orally with 4-8 oz. of water according to the labeled directions of the currently marketed product (i.e., 2 caplets after first loose stool, followed by 1 caplet after each subsequent loose stool, not to exceed 4 caplets in 24 hours). The treatment period will last six hours.
DRUG	matching placebo	Four placebo caplets matching the caplets in Arm 1, administered orally with 4-8 oz. of water according to the labeled directions of the currently marketed product (i.e., 2 caplets after first loose stool, followed by 1 caplet after each subsequent loose stool, not to exceed 4 caplets in 24 hours). The treatment period will last six hours.

Timeline

• Start date: 2008-10-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-05-28
• Last updated: 2011-10-06

Locations

1 site across 1 country: Mexico