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

NCT02340481 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2016-01-07

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Xian-Janssen Pharmaceutical Ltd.

    lead INDUSTRY

Principal Investigators

  • Xian-Janssen Pharmaceutical Ltd., China Clinical Trial · Xian-Janssen Pharmaceutical Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2006-05-31
Completion
2006-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02340481 on ClinicalTrials.gov