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A Study to Evaluate Topical Phenylephrine Gel in the Management of Faecal Incontinence

Faecal Incontinence Clinical Trial

Official title:
A Double-blind, Randomised, Placebo-controlled Study to Evaluate Topical 10% Phenylephrine Gel in the Management of Ileal Pouch Anal Anastomosis (IPAA)-Related Faecal Incontinence

Clinical Trial Summary

The aim of the study is to test the hypothesis that topical application of phenylephrine improves faecal continence and quality of life in subjects with passive faecal incontinence after ileo-anal pouch construction.

Clinical Trial Description

Faecal seepage and even frank incontinence at night can be a problem for approximately 30% of patients who have undergone ileal pouch anal anastomosis (IPAA). Nocturnal seepage may be a problem in patients who do not have gross incontinence, or who may even have no incontinence during the day. Although baseline continence during the day is maintained by involuntary control of the internal anal sphincter, this can be supplemented by voluntary contraction of the external sphincter. While sleeping, this supplementary external sphincter effect is lost and internal anal sphincter tone is reduced, leading to seepage. This is obviously distressing and leads some patients to wear a pad to reduce the soiling that may occur.

The primary objective is to determine the effect of 10% phenylephrine hydrochloride gel, applied three times a day, on the change from baseline to the end of study (8 weeks)in the faecal incontinence score (St Mark's) with passive faecal incontinence after ileo-anal pouch construction, compared with placebo. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00420797
Study type Interventional
Source S.L.A. Pharma AG
Contact
Status Withdrawn
Phase Phase 3
Start date February 2007
Completion date November 2007
View Details
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