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

Sponsored by:	Johnson & Johnson Consumer & Personal Products Worldwide
Information provided by:	Johnson & Johnson Consumer & Personal Products Worldwide
ClinicalTrials.gov Identifier:	NCT00685607

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 IV

MedlinePlus related topics: Diarrhea

Drug Information available for: Simethicone Loperamide Loperamide hydrochloride

U.S. FDA Resources

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

Further study details as provided by Johnson & Johnson Consumer & 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
1: Experimental 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.
2: Placebo Comparator 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.

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

Sponsors and Collaborators

Johnson & Johnson Consumer & Personal Products Worldwide

Investigators

Study Chair:

Herbert L DuPont, MD

Department of Public Health, University of Texas, Houston School of Public Health

More Information

Responsible Party:	J&JCPPW ( Joyce Hauze/Senior Project Manager )
Study ID Numbers:	LOPDIR4003
Study First Received:	May 23, 2008
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00685607
Health Authority:	Mexico: Ethics Committee

Keywords provided by Johnson & Johnson Consumer & Personal Products Worldwide:

Pilot Study
Outcome Measures

Study placed in the following topic categories:

Simethicone
Signs and Symptoms
Diarrhea
Signs and Symptoms, Digestive
Loperamide

Additional relevant MeSH terms:

Therapeutic Uses
Gastrointestinal Agents
Dermatologic Agents

Pharmacologic Actions
Emollients
Antidiarrheals

ClinicalTrials.gov processed this record on January 16, 2009