NCT02340481

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

A Multi-center, Randomized, Double-blind, Double-dummy, and Parallel Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Loperamide Hydrochloride/Simethicone Chewable Tablet in the Treatment of Acute Diarrhea With Abdominal Discomfort and Flatulence

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: Xian-Janssen Pharmaceutical Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized (the study drug is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), parallel-group (each group of participants will be treated at the same time), multi-center (when more than one hospital or medical school team work on a medical research study) study. All eligible participants will be randomly assigned to receive either a combination of loperamide hydrochloride and simethicone or loperamide hydrochloride. The study includes Screening Visit (from -24 to 0 hours), Baseline Visit (at 0 hour) and Concluding Visit (within 48 to 96 hours following the start of the trial). The timing of each bowel movement, stool characteristics and the degree and duration of abdominal discomfort caused by gastrointestinal gas accumulation will be recorded for each participant for 48 hours after the first trial drug administration. Participants' safety will be monitored throughout the study.

Conditions

• Diarrhea

Interventions

Type	Name	Description
DRUG	Loperamide hydrochloride + simethicone chewable tablet	Each tablet contains 2 milligram (mg) of loperamide hydrochloride and 125 mg of simethicone.
DRUG	Loperamide hydrochloride	Each capsule contains 2 mg of loperamide hydrochloride
DRUG	Loperamide hydrochloride + simethicone chewable placebo tablet	Placebo matched to loperamide hydrochloride and simethicone chewable tablet.
DRUG	Loperamide hydrochloride placebo capsule	Placebo matched to loperamide hydrochloride capsule.

Timeline

• Start date: 2005-07-01
• Primary completion: 2006-05-01
• Completion: 2006-05-01
• First posted: 2015-01-16
• Last updated: 2016-01-07

Locations

4 sites across 1 country: China