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

A Placebo-Controlled, Double-Blind, Randomized Pilot Study to Evaluate the Appropriateness of Multiple Endpoints in Measuring the Onset of Clinical Efficacy of Loperamide-Simethicone Caplets in the Treatment of Acute Non-specific Diarrhea

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.

Study Overview

• Status: Completed
• Conditions: Diarrhea
• Intervention / Treatment: Drug: loperamide-simethicone; Drug: matching placebo

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 4

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44100
      • Universidad Autonoma de Guadalajara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; matching placebo	Drug: matching placebo; Four placebo caplets matching the caplets in Arm 1, administered orally with 4-8 oz. of water according to the labeled directions of the currently marketed product (i.e., 2 caplets after first loose stool, followed by 1 caplet after each subsequent loose stool, not to exceed 4 caplets in 24 hours). The treatment period will last six hours.; Other Names: Placebo
Experimental: 1; loperamide-simethicone	Drug: loperamide-simethicone; Four caplets containing 2 mg loperamide HCl and 125 mg of simethicone each, administered orally with 4-8 oz. of water according to the labeled directions of the currently marketed product (i.e., 2 caplets after first loose stool, followed by 1 caplet after each subsequent loose stool, not to exceed 4 caplets in 24 hours). The treatment period will last six hours.; Other Names: Imodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate Multiple Endpoints	6 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to improvement in stool form	6 hours
Time to improvement in urge to defecate	6 hours
Time to improvement in gas-related abdominal discomfort	6 hours
Time to improvement of change in normal activities of daily living	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

Collaborators and Investigators

• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Investigators: Study Chair: Herbert L DuPont, MD, Department of Public Health, University of Texas, Houston School of Public Health

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: May 23, 2008
• First Submitted That Met QC Criteria: May 27, 2008
• First Posted (Estimate): May 28, 2008

Study Record Updates

• Last Update Posted (Estimate): October 6, 2011
• Last Update Submitted That Met QC Criteria: October 4, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Outcome Measures; Pilot Study
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Dermatologic Agents; Antifoaming Agents; Emollients; Simethicone; Loperamide; Antidiarrheals
• Other Study ID Numbers: LOPDIR4003