Study to Determine the Best Way to Measure How Quickly the Drug Can Give Relief From Sudden Diarrhea

Phase 4

Completed

• Conditions: Diarrhea
• Interventions: Drug: loperamide-simethicone; Drug: matching placebo

• Registration Number: NCT00685607
• Lead Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide

Brief Summary

For six hours following drug administration, subjects will rate the severity of specific symptoms. At the end of the six hour study, subjects will rate the overall effectiveness of the product.

Detailed Description

A six-hour study to evaluate multiple early efficacy endpoints in loperamide-simethicone therapy to help identify speed of onset of symptomatic treatment of acute nonspecific diarrhea (ANSD).

Study Timeline

• Study First Submitted: 2008-05-23
• Study First Submitted QC: 2008-05-27
• Study First Posted: 2008-05-28
• Study Start: 2008-10
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-04
• Last Update Posted: 2011-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Diagnosis of acute diarrhea with gas-related abdominal discomfort, meeting specific criteria
• Willing to follow the protocol requirements and comply with protocol restrictions, including use of contraception
• Able to understand the informed consent process and sign the form
• Cooperative, reliable and willing to comply with the protocol requirements and schedule, and able to record efficacy and safety assessments.

Exclusion Criteria

• Female subjects who are pregnant, lactating or experiencing perimenstrual abdominal or pelvic discomfort
• Illness requires hospitalization, IV fluids or antibiotics
• Has taken antibiotics in the past 7 days or a symptomatic antidiarrheal compound in the past 12 hours or any analgesic in the past 6 hours
• History of significant underlying enteric, pulmonary, hepatic, cardiac, renal disease, seizure disorder, IBD, cancer, uncontrolled diabetes, or any other unstable medical condition
• History of hypersensitivity to loperamide or simethicone
• Has previously participated in this study or received an investigational drug within the 30 day period before screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	loperamide-simethicone	loperamide-simethicone
2	matching placebo	matching placebo

Primary Outcome Measures

Name	Time	Method
Evaluate Multiple Endpoints	6 hours

Secondary Outcome Measures

Name	Time	Method
Time to improvement of change in normal activities of daily living	6 hours
Time to improvement in gas-related abdominal discomfort	6 hours
Time to improvement in stool form	6 hours
Time to improvement in urge to defecate	6 hours
Subject global impression of efficacy of study medication at the end of the treatment period	6 hours
Physical examination and vital signs at the screening visit and the monitoring of adverse events throughout the course of the study	6 hours

Trial Locations

Locations (1)

Universidad Autonoma de Guadalajara; 🇲🇽 Guadalajara, Jalisco, Mexico