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

PHASE3CompletedINTERVENTIONAL
Enrollment

217

Participants

Timeline

Start Date

July 31, 2005

Primary Completion Date

May 31, 2006

Study Completion Date

May 31, 2006

Conditions
Diarrhea
Interventions
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.

Trial Locations (4)

Unknown

Beijing

Guangzhou

Nanjing

Shanghai

All Listed Sponsors
lead

Xian-Janssen Pharmaceutical Ltd.

INDUSTRY

NCT02340481 - Efficacy and Safety Study of Loperamide Hydrochloride/Simethicone Chewable Tablet in Treatment of Acute Diarrhea With Abdominal Discomfort and Flatulence | Biotech Hunter | Biotech Hunter