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

NCT02340481 Phase 3 COMPLETED

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.

Details

Lead sponsor	Xian-Janssen Pharmaceutical Ltd.
Phase	Phase 3
Status	COMPLETED
Enrolment	217
Start date	2005-07
Completion	2006-05

Conditions

• Diarrhea

Interventions

• Loperamide hydrochloride + simethicone chewable tablet
• Loperamide hydrochloride
• Loperamide hydrochloride + simethicone chewable placebo tablet
• Loperamide hydrochloride placebo capsule

Primary outcomes

• Time to Last Unformed Stool (TTLUS) — 48 hours
  The TTLUS is defined as the number of hours from the time the participant first took the trial drug to the last instance of unformed stool, after which the participant only reported formed stool or no stool at all. If no unformed stool was observed at any time during the trial, TTLUS shall be recorded as 0. For participants who withdraw from the trial due to reasons other than complete resolution of the symptoms of diarrhea, TTLUS is defined as the number of hours from the start of the trial to the time of withdrawal.
• Time to Complete Amelioration of Abdominal Discomfort — 48 hours
  The time over which abdominal discomfort caused by gastrointestinal gas accumulation is completely resolved.

Countries

China