drugset / Trial / NCT02340481

Efficacy and Safety Study of Loperamide Hydrochloride/Simethicone Chewable Tablet in Treatment of Acute Diarrhea With Abdominal Discomfort and Flatulence

NCT02340481

Phase 3 Completed 217 enrolled Xian-Janssen Pharmaceutical Ltd.
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of combined loperamide hydrochloride and simethicone compared to loperamide hydrochloride monotherapy in treating acute diarrhea associated with abdominal discomfort caused by gastrointestinal gas accumulation.

Timeline

Start
2005-07
Primary completion
2006-05
Completion
2006-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Loperamide Small molecule 2 mg Oral
Subject Simethicone Other / unclassified 125 mg Oral

Indications