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

NCT ID: NCT02340481

Last Updated: 2016-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 217 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2006-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Loperamide Hydrochloride + Simethicone

Participant will take 2 loperamide hydrochloride and simethicone chewable tablets + 2 loperamide hydrochloride placebo capsules orally, as their first dose, and subsequently 1 loperamide hydrochloride and simethicone chewable tablet + 1 loperamide hydrochloride placebo capsule orally, in the event of unformed stool (provided that no more than 4 tablets/capsules are taken within a 24-hour period) up to 48 hours.

Group Type: EXPERIMENTAL

Loperamide hydrochloride + simethicone chewable tablet

Intervention Type: DRUG

Each tablet contains 2 milligram (mg) of loperamide hydrochloride and 125 mg of simethicone.

Loperamide hydrochloride placebo capsule

Intervention Type: DRUG

Placebo matched to loperamide hydrochloride capsule.

Loperamide Hydrochloride

Participant will take 2 loperamide hydrochloride capsules + 2 loperamide hydrochloride and simethicone chewable placebo tablets orally, as their first dose, and subsequently 1 loperamide hydrochloride capsule + 1 loperamide hydrochloride and simethicone chewable placebo tablet orally, in the event of unformed stool (provided that no more than 4 capsules/tablets are taken within a 24-hour period) up to 48 hours.

Group Type: ACTIVE_COMPARATOR

Loperamide hydrochloride

Intervention Type: DRUG

Each capsule contains 2 mg of loperamide hydrochloride

Loperamide hydrochloride + simethicone chewable placebo tablet

Intervention Type: DRUG

Placebo matched to loperamide hydrochloride and simethicone chewable tablet.

Interventions

Loperamide hydrochloride + simethicone chewable tablet

Each tablet contains 2 milligram (mg) of loperamide hydrochloride and 125 mg of simethicone.

Intervention Type: DRUG

Loperamide hydrochloride

Each capsule contains 2 mg of loperamide hydrochloride

Intervention Type: DRUG

Loperamide hydrochloride + simethicone chewable placebo tablet

Placebo matched to loperamide hydrochloride and simethicone chewable tablet.

Intervention Type: DRUG

Loperamide hydrochloride placebo capsule

Placebo matched to loperamide hydrochloride capsule.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participant's symptoms of acute diarrhea must manifest within 48 hours prior to entering the trial
• Participant must have experienced at least three incidences of unformed stool within 24 hours prior to entering the trial (referring to any instances of watery stool or soft stool as determined after placing the stool in a container)
• Participant's most recently produced stool must be unformed stool
• Participant must give a positive answer to the following question: "Have you felt any abdominal discomfort caused by gastrointestinal gas accumulation within the last hour"
• Female participants must take effective contraceptive measures throughout the trial (including oral or injectable contraceptives, contraceptive tools, ligation) or be postmenopausal

Exclusion Criteria

• Participant hospitalized for treatment of severe acute diarrhea or otherwise requires intravenous fluids or antibiotics on an outpatient basis
• Participant shows an axillary temperature greater than (>) 38.2 degrees Celsius (C) or an oral temperature > 38.6 degrees C
• Participant shows clinical symptoms of bloody or purulent stool or erythrocytes or leukocytes are detected in the participant's stool at > 3 per high power field
• Participant shows a sitting systolic blood pressure less than (<) 90 millimeter of mercury (mmHg) and/ or diastolic blood pressure < 60 mmHg
• Participant is unable to take medication orally or tolerate oral rehydration

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xian-Janssen Pharmaceutical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xian-Janssen Pharmaceutical Ltd., China Clinical Trial

Role: STUDY_DIRECTOR

Xian-Janssen Pharmaceutical Ltd.

Locations

Beijing, , China

Guangzhou, , China

Nanjing, , China

Shanghai, , China

Countries

China

Other Identifiers

LOPDIR3001

Identifier Type: OTHER

Identifier Source: secondary_id

CR103534

Identifier Type: -

Identifier Source: org_study_id