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Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence — FIRM  

Fecal Incontinence Clinical Trial

Official title:
Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence

Clinical Trial Summary

The purpose of this study is to evaluate and compare treatment with fiber and loperamide for fecal incontinence.

Clinical Trial Description

Fecal incontinence (FI) affects 4-24% adults in the community and greatly impacts quality of life. Both fiber and loperamide are common, first-line treatments for diarrhea-associated FI in primary care. No known studies exist that compare fiber and loperamide for diarrhea-predominant FI. Further knowledge is needed to define which treatment is more effective and to compare drug tolerability (side effects) for FI. This study will also look at changes in quality of life with treatment and potential mechanisms of drug treatment. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00727649
Study type Interventional
Source VA Office of Research and Development
Contact
Status Completed
Phase Phase 2/Phase 3
Start date July 2008
Completion date December 2013
View Details
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