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

Study Overview
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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).

Official Title
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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

Conditions
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Diarrhea

Intervention / Treatment
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* Drug: loperamide-simethicone
* Drug: matching placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>loperamide-simethicone | Drug: loperamide-simethicone<br>* 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.<br>* Other names: Imodium;|
| Placebo Comparator: 2<br>matching placebo | Drug: matching placebo<br>* 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.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate Multiple Endpoints |  | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Physical examination and vital signs at the screening visit and the monitoring of adverse events throughout the course of the study |  | 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pilot Study, Outcome Measures