At a glance
ClinicalIndex Comparison Record- ✓Female aged 18–80 years
- ✓Urge-predominant or combined (urge plus passive) fecal incontinence for ≥1 year duration
- ✓≥1 episode of fecal incontinence per week (averaged over 2 weeks)
- ✓Average Bristol stool score ≥3
- ✕Clinically serious cardiovascular or pulmonary disease or EKG showing 2nd degree atrioventricular block or higher
- ✕History of rectal cancer, scleroderma, inflammatory bowel disease, small bowel obstruction, congenital anorectal abnormalities, Grade 2 rectal prolapse, rectal resection, or pelvic irradiation
- ✕Neurological disorders including spinal cord injuries, dementia (Mini-Mental Status Score <21), multiple sclerosis, Parkinson's disease, or peripheral neuropathy
- ✕Symptomatic hypotension or systolic blood pressure <100 mmHg on initial visit
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Placebo Controlled Study of Colesevelam in Fecal Incontinence
In Brief
A Phase 3 clinical trial evaluating Colesevelam, Clonidine, and 1 other intervention for Fecal Incontinence and Bile Acid Malabsorption. Completed, enrolled 88 participants across 1 site.
Detailed Summary
Compare the effects of a combination of colesevelam and clonidine to placebo on bowel symptoms in patients with urge or combined type of FI.
Study Details
Timeline
Interventions
Participants who satisfy symptom criteria in Phase 2 will be randomized in a 1:1 ratio to receive either a combination of colesevelam (1.875 gm twice daily) and clonidine (0.1 mg oral twice daily) or an identical placebo for 4 weeks.
Participants who satisfy symptom criteria in Phase 2 will be randomized in a 1:1 ratio to receive either a combination of colesevelam (1.875 gm twice daily) and clonidine (0.1 mg oral twice daily) or an identical placebo for 4 weeks.
Placebo will be identical in appearance to the active drug.