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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:
NCT00685607
First received: May 23, 2008
Last updated: October 4, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Diarrhea
 Drug: loperamide-simethicone
Drug: matching placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • Evaluate Multiple Endpoints [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to improvement in stool form [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Time to improvement in urge to defecate [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Time to improvement in gas-related abdominal discomfort [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Time to improvement of change in normal activities of daily living [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Subject global impression of efficacy of study medication at the end of the treatment period [ Time Frame: 6 hours ] [ Designated as 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 ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: October 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Imodium
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 Name: 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00685607

Locations
Mexico
Universidad Autonoma de Guadalajara
Guadalajara, Jalisco, Mexico, 44100
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT00685607     History of Changes
Other Study ID Numbers: LOPDIR4003
Study First Received: May 23, 2008
Last Updated: October 4, 2011
Health Authority: Mexico: Ethics Committee

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
Pilot Study
Outcome Measures

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Loperamide
Antidiarrheals
Simethicone
 Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Emollients
Dermatologic Agents

ClinicalTrials.gov processed this record on May 16, 2013