A Placebo-Controlled Study of Clonidine for Fecal Incontinence.

Phase 2 Completed 44 enrolled Mayo Clinic National Center for Research Resources (NCRR) · collab National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2008-10
Primary completion: 2012-08
Completion: 2012-08

Outcome

Missed primary endpoint

paper Clonidine did not affect FI symptom severity, bowel symptoms (stool consistency or frequency), anal pressures, rectal compliance, or sensation compared with placebo. PMID 23891925 ↗

Publications

Bharucha AE, Fletcher JG, Camilleri M, Edge J, Carlson P, Zinsmeister AR. Effects of clonidine in women with fecal incontinence. Clin Gastroenterol Hepatol. 2014 May;12(5):843-851.e2; quiz e44. doi: 10.1016/j.cgh.2013.06.035. Epub 2013 Jul 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Clonidine	Other / unclassified	0.1 mg	Oral

Indications

No indication recorded.