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

May 23, 2008
October 4, 2011
October 2008
October 2008   (final data collection date for primary outcome measure)
Evaluate Multiple Endpoints [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00685607 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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: Yes ]
Not Provided
Not Provided
 
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.

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).

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diarrhea
  • 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
  • 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
  • Experimental: 1
    loperamide-simethicone
    Intervention: Drug: loperamide-simethicone
  • Placebo Comparator: 2
    matching placebo
    Intervention: Drug: matching placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT00685607
LOPDIR4003
No
Johnson & Johnson Consumer and Personal Products Worldwide
Johnson & Johnson Consumer and Personal Products Worldwide
Not Provided
Study Chair: Herbert L DuPont, MD Department of Public Health, University of Texas, Houston School of Public Health
Johnson & Johnson Consumer and Personal Products Worldwide
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP