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

NCT00685607 | Completed Phase 4

• 1 other identifier: LOPDIR4003
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea

Keywords

Pilot Study; Outcome Measures

Outcome Measures

Primary Outcomes (1)

• Evaluate Multiple Endpoints

  6 hours

Secondary Outcomes (6)

• Time to improvement in stool form

  6 hours

• Time to improvement in urge to defecate

  6 hours

• Time to improvement in gas-related abdominal discomfort

  6 hours

• Time to improvement of change in normal activities of daily living

  6 hours

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

  6 hours

Study Arms (2)

1

EXPERIMENTAL

loperamide-simethicone

Drug: loperamide-simethicone

2

PLACEBO COMPARATOR

matching placebo

Drug: matching placebo

Interventions

loperamide-simethicone 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.

Also known as: Imodium

1

matching placebo 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.

Also known as: Placebo

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide: lead

Study Sites (1)

Universidad Autonoma de Guadalajara

Guadalajara, Jalisco, 44100, Mexico

Location

MeSH Terms

Conditions

Diarrhea

Interventions

Loperamide

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Herbert L DuPont, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2008
• First Posted: May 28, 2008
• Study Start: October 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: October 6, 2011

Record last verified: 2011-10

Locations

ME (1)