IRB Number:

08-005892

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

This study is being done to learn if clonidine improves symptoms in women with rectal urgency and fecal incontinence (involuntary stool leakage). Clonidine is an approved drug for treating high blood pressure. By relaxing the rectum, clonidine may give patients with fecal incontinence more time to reach the toilet.

Who is Eligible to Participate in the Study?

Women (aged 18-75 years) who experience fecal incontinence and urgency and do not have an organic disorder (e.g., rectal cancer, scleroderma, inflammatory bowel disease, significant rectal prolapse or neurological conditions)

Minimum Age:

18

Maximum Age:

75

What is Involved With this Study?

The study lasts 8 weeks (4 weeks without study medication, then 4 weeks on medication/placebo). Bowel diaries and questionnaires are maintained during this period. Anorectal motility will be assessed before and after medication periods. A pelvic MRI will also be performed.

How long will the Study run?

8 weeks

Who can I Contact for Additional Information on this Trial?

For more information or to participate in this research study, please call the research study coordinator Barb Seide at (507) 255-6802 or seide.barbara@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 05/04/2009