A Comparison of Three Medications to Treat Diarrhea in Adults.

PHASE4CompletedINTERVENTIONAL
Enrollment

415

Participants

Timeline

Start Date

November 30, 2008

Primary Completion Date

August 31, 2009

Study Completion Date

November 30, 2009

Conditions
Diarrhea
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)

Trial Locations (6)

22447

North West Medical, San José del Cabo

37700

Dr. Maxwell´s Clinic, San Miguel de Allende

48300

Hospital Amerimed Puerto Vallarta, Puerto Vallarta

Servicios Medicos de la Bahia, Puerto Vallarta

403004

Manipal Goa Hospital, Mormugao

403527

Vrundavan Hospital & Research Centre, Mormugao

Sponsors

Lead Sponsor

All Listed Sponsors
lead

McNeil AB

INDUSTRY