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

NCT ID: NCT00685607

Last Updated: 2011-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2008-10-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

loperamide-simethicone

Group Type EXPERIMENTAL

loperamide-simethicone

Intervention Type DRUG

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

matching placebo

Group Type PLACEBO_COMPARATOR

matching placebo

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Imodium Placebo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson Consumer and Personal Products Worldwide

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Herbert L DuPont, MD

Role: STUDY_CHAIR

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

Locations

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Universidad Autonoma de Guadalajara

Guadalajara, Jalisco, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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LOPDIR4003

Identifier Type: -

Identifier Source: org_study_id