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

Primary Purpose

Diarrhea

Status

Completed

Phase

Phase 4

Locations

Mexico

Study Type

Interventional

Intervention

loperamide-simethicone

matching placebo

About this trial

This is an interventional treatment trial for Diarrhea focused on measuring Pilot Study, Outcome Measures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Universidad Autonoma de Guadalajara

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

loperamide-simethicone

matching placebo

Outcomes

Primary Outcome Measures

Evaluate Multiple Endpoints

Secondary Outcome Measures

Time to improvement in stool form

Time to improvement in urge to defecate

Time to improvement in gas-related abdominal discomfort

Time to improvement of change in normal activities of daily living

Subject global impression of efficacy of study medication at the end of the treatment period

Physical examination and vital signs at the screening visit and the monitoring of adverse events throughout the course of the study

Full Information

NCT ID

NCT00685607

First Posted

May 23, 2008

Last Updated

October 4, 2011

Sponsor

Johnson & Johnson Consumer and Personal Products Worldwide

1. Study Identification

Unique Protocol Identification Number

NCT00685607

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johnson & Johnson Consumer and Personal Products Worldwide

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diarrhea

Keywords

Pilot Study, Outcome Measures

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

loperamide-simethicone

Arm Title

Arm Type

Placebo Comparator

Arm Description

matching placebo

Intervention Type

Drug

Intervention Name(s)

loperamide-simethicone

Other Intervention Name(s)

Imodium

Intervention Description

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

Intervention Name(s)

matching placebo

Other Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Evaluate Multiple Endpoints

Time Frame

6 hours

Secondary Outcome Measure Information:

Title

Time to improvement in stool form

Time Frame

6 hours

Title

Time to improvement in urge to defecate

Time Frame

6 hours

Title

Time to improvement in gas-related abdominal discomfort

Time Frame

6 hours

Title

Time to improvement of change in normal activities of daily living

Time Frame

6 hours

Title

Subject global impression of efficacy of study medication at the end of the treatment period

Time Frame

6 hours

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Herbert L DuPont, MD

Organizational Affiliation

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

Official's Role

Study Chair

Facility Information:

Facility Name

Universidad Autonoma de Guadalajara

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44100

Country

Mexico

12. IPD Sharing Statement

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

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