A Comparison of Three Medications to Treat Diarrhea in Adults.
NCT00807326 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 415
Last updated 2012-07-10
Summary
A comparison of three medications to treat diarrhea in adults.
Conditions
Interventions
- DRUG
-
Loperamide/simeticone 2 mg/125 mg caplets
Oral, 2 caplets taken initially at investigator site followed by one caplet after each unformed stool, maximum 4 caplets in a 24 hour period for a maximum of 48 hours (per product label)
- DRUG
-
Loperamide/simeticone 2 mg/125 mg chewable tablets
Oral, 2 chewable tablets taken initially at the site followed by one chewable tablet after each unformed stool, maximum 4 chewable tablets in a 24 hour period for a maximum of 48 hours (per product label)
- DRUG
-
Probiotic Saccharomyces boulardii 250 mg capsules
Oral, 1 capsule twice a day, maximum 2 capsules in a 24 hour period for a maximum of 5 days (per product label)
Sponsors & Collaborators
-
McNeil AB
lead INDUSTRY
Principal Investigators
-
Elisabeth Kruse, PhD · McNeil AB
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-11-30
- Primary Completion
- 2009-08-31
- Completion
- 2009-11-30
Countries
- India
- Mexico
Study Locations
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