CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
Clonidine +1 moredrug
Likely dose
Clonidine 0.1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00884832
NCT00884832Phase 2Completed

A Placebo-Controlled Study of Clonidine for Fecal Incontinence.

Mayo Clinic·interventional·Posted Apr 21, 2009·Updated Mar 6, 2014

In Brief

A Phase 2 clinical trial evaluating Clonidine and Placebo for Fecal Incontinence. Completed, enrolled 44 participants across 1 site.

Detailed Summary

Fecal incontinence is the involuntary leakage of stool from the anus. Doctors at Mayo Clinic are doing a research study to assess the effects of a medication, clonidine, on fecal incontinence and rectal functions in women. Clonidine has been approved by the Food and Drug Administration (FDA) for treating high blood pressure, but not for treating incontinence and rectal functions. The hypothesis of this study is clonidine will improve fecal incontinence, increase rectal capacity and reduce rectal sensation to a greater extent than placebo in women.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 21, 2009
Enrollment StartOct 1, 2008
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 17.2 years ago

Interventions

Clonidinedrug

Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.

Placebodrug

Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.