Clinical trial NCT00685607: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diarrhea
Keywords: Pilot Study
Outcome Measures
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2008-05-28
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Evaluate Multiple Endpoints
timeFrame: 6 hours
Secondary outcomes:
measure: Time to improvement in stool form
timeFrame: 6 hours
measure: Time to improvement in urge to defecate
timeFrame: 6 hours
measure: Time to improvement in gas-related abdominal discomfort
timeFrame: 6 hours
measure: Time to improvement of change in normal activities of daily living
timeFrame: 6 hours
measure: Subject global impression of efficacy of study medication at the end of the treatment period
timeFrame: 6 hours
measure: Physical examination and vital signs at the screening visit and the monitoring of adverse events throughout the course of the study
timeFrame: 6 hours
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Universidad Autonoma de Guadalajara
state: Jalisco
Study officials:
affiliation: Department of Public Health, University of Texas, Houston School of Public Health
name: Herbert L DuPont, MD
role: STUDY_CHAIR
References: