Phase 2
Completed N=44
A Placebo-Controlled Study of Clonidine for Fecal Incontinence.
Source: ClinicalTrials.gov NCT00884832 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcomePrimary: Mean Fecal Incontinence and Constipation Assessment (FICA) Score — 8.1; 9.1; 6.5; 7.6 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Fecal Incontinence and Constipation Assessment (FICA) Score |
8.1; 9.1; 6.5; 7.6 | — |
| SECONDARY Mean Number of Days With Fecal Incontinence |
13; 16; 8; 11 | — |
| SECONDARY Mean Number of Fecal Incontinence Episodes |
20; 31; 12; 19 | — |
| SECONDARY Mean Percentage of Bowel Movements Which Were Incontinent |
31; 40; 24; 27 | — |
| SECONDARY Mean Severity of Fecal Incontinence |
36.2; 37.3; 29.3; 31.2 | — |
| SECONDARY Impact of Fecal Incontinence on Baseline Quality of Life |
2.8; 2.3; 1.8; 1.6; 3.2; 2.9 | — |
| SECONDARY Impact of Fecal Incontinence on Post-Treatment Quality of Life |
3.1; 2.7; 2.3; 2.1; 3.5; 3.2 | — |
| SECONDARY Satisfaction With Treatment |
22; 18; 47; 38 | — |
| SECONDARY Percentage of Bowel Movements Preceded by Rectal Urgency |
55; 59; 46; 46 | — |
| SECONDARY Percentage of Bowel Movements With Semi-formed and Loose Stools in Subjects With and Without Diarrhea |
19.4; 25.5; 47.5; 51.6; 14; 16 | <0.001 sig |
| SECONDARY Percentage of Bowel Movements With Semi-formed and Loose Stools Post-treatment Adjusted for Baseline |
23.6; 38.7; 25.4; 22.8 | 0.018 sig |
| SECONDARY Percentage of Days With Fecal Incontinence (FI) |
28.7; 37.8; 35.4; 42.1; 23.2; 18.7 | — |
| SECONDARY Percentage of Days With FI Post-treatment Adjusted for Baseline |
42.54; 31.42; 27.79; 39.51 | 0.082 |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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 ( 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)
Data sourced from ClinicalTrials.gov (NCT00884832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.