A Comparison of Three Medications to Treat Diarrhea in Adults.

NCT00807326 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 415

Last updated 2012-07-10

No results posted yet for this study

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

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00807326 on ClinicalTrials.gov