Status:
COMPLETED
A Placebo-Controlled Study of Clonidine for Fecal Incontinence.
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Conditions:
Fecal Incontinence
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief 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 rect...
Detailed Description
Available therapeutic options for idiopathic fecal incontinence (FI) are limited and unsatisfactory. In addition to weak anal sphincters, our data suggest that reduced rectal capacity may contribute t...
Eligibility Criteria
Inclusion
- Women aged 18-75 years with urge predominant FI, as defined by a validated questionnaire, for greater than or equal to 1 year duration will be eligible to participate
- Absence of organic disease (i.e., ulcerative colitis, cancer) as evidenced by colonoscopy, or barium enema and sigmoidoscopy within the last 3 years
Exclusion
- History of clinically significant cardiovascular or pulmonary disease or EKG abnormalities within the last 6 months \[i.e., atrial flutter or fibrillation, sinus tachycardia (\> 110/minute) or bradycardia (\< 45 beats/minute), or prolonged corrected QT (QTc) interval (\> 460 msec)
- Current or past history of rectal cancer, scleroderma, inflammatory bowel disease, congenital anorectal abnormalities, greater than or equal to Grade 2 rectal prolapse, history of rectal resection or pelvic irradiation
- Neurological disorders - Spinal cord injuries, dementia (Mini-mental status score \<20/25), multiple sclerosis, Parkinson's disease, peripheral neuropathy
- Conditions precluding safe use of clonidine, i.e., symptomatic hypotension, or systolic blood pressure of \<100 mm Hg on initial screening visit
- Pregnant or nursing women
- Severe diarrhea during the run in phase defined as greater than 6 liquid stools daily (Bristol 6 or 7)
- Medications: Absolute - opioid analgesics, anticholinergic drugs \[low doses of tricyclic antidepressants, e.g., nortriptyline (up to 50 mg/day) or amitriptyline (up to 25 mg/day) will be permitted provided they were begun 3 months prior to the screening period\]
- Medications: Relative - other antihypertensive agents (i.e., if there is concern about synergistic effects and hypotension)
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00884832
Start Date
October 1 2008
End Date
August 1 2012
Last Update
March 6 2014
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905