Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study

Study Primary Completion Date: November 2008

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).

Intervention(s) in this Clinical Trial

• 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.
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • loperamide-simethicone
• Placebo Comparator: 2
  • matching placebo

Primary Measures

• Evaluate Multiple Endpoints
  • Time Frame: 6 hours
    Safety Issue?: No

Secondary Measures

• Time to improvement in stool form
  • Time Frame: 6 hours
    Safety Issue?: No
• Time to improvement in urge to defecate
  • Time Frame: 6 hours
    Safety Issue?: No
• Time to improvement in gas-related abdominal discomfort
  • Time Frame: 6 hours
    Safety Issue?: No
• Time to improvement of change in normal activities of daily living
  • Time Frame: 6 hours
    Safety Issue?: No
• Subject global impression of efficacy of study medication at the end of the treatment period
  • Time Frame: 6 hours
    Safety Issue?: No
• Physical examination and vital signs at the screening visit and the monitoring of adverse events throughout the course of the study
  • Time Frame: 6 hours
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Johnson & Johnson Consumer & Personal Products Worldwide

Overall Clinical Trial Officials and Contacts

Herbert L DuPont, MD Study Chair Department of Public Health, University of Texas, Houston School of Public Health  

Overall Contact: Joyce L Hauze, MBA, CCRA 973-385-6104 jhauze@conus.jnj.com

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00685607

Study ID Number: LOPDIR4003

ClinicalTrials.gov Identifier: NCT00685607

Health Authority: Mexico: Ethics Committee