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

Diarrhea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00685607
• Other study ID #: LOPDIR4003
• Status: Completed
• Phase: Phase 4
• First received: May 23, 2008
• Last updated: October 4, 2011
• Start date: October 2008
• Est. completion date: October 2008

Study information

• Verified date: October 2011
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diarrhea

Intervention

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.
• 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.

Locations

Country	Name	City	State
Mexico	Universidad Autonoma de Guadalajara	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Consumer and Personal Products Worldwide

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate Multiple Endpoints		6 hours	No
Secondary	Time to improvement in stool form		6 hours	No
Secondary	Time to improvement in urge to defecate		6 hours	No
Secondary	Time to improvement in gas-related abdominal discomfort		6 hours	No
Secondary	Time to improvement of change in normal activities of daily living		6 hours	No
Secondary	Subject global impression of efficacy of study medication at the end of the treatment period		6 hours	No
Secondary	Physical examination and vital signs at the screening visit and the monitoring of adverse events throughout the course of the study		6 hours	No