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Clinical Trial Summary

The purpose of this study is to assess the effect and safety of alpha agonist ointment on fecal incontinence severity in patients with idiopathic fecal incontinence.


Clinical Trial Description

This is a double blinded cross over study. Approximately 40 subjects will be participating in this 4 weeks study. A screening visit will be used to determine eligibility for the study. Patients found eligible will receive alpha agonist ointment or placebo ointment for 2 weeks. This will be followed by a second 2 weeks treatment cycle in which:

- patients previously treated with alpha agonist will be treated with placebo.

- patients previously treated with placebo will be treated with alpha agonist. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT01421823
Study type Interventional
Source RDD Pharma Ltd
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Start date August 2011