Clinical Trials

Inclusion Criteria 

• Phase 1 and 2
  • Females aged 18-80 years with urge predominant or combined urge plus passive fecal incontinence for at least 1 year, as defined by questionnaire
• Phase 3
  • Completion of at least 5 out of 7 days of the diary in the preceding week and 10 out of 14 in the preceding 2 weeks
  • At least 1 episode of fecal incontinence per week averaged over 2 weeks
  • Average Bristol stool score of 3 or higher
  • Average stool frequency of ≥ 1/day
• Phase 4
  • All patients who complete at least 1 week of treatment with study drugs or placebo

Exclusion Criteria

• Phase 1
  • History of clinically serious cardiovascular or pulmonary disease or EKG showing 2nd degree atrioventricular block or higher
  • Current or past history of
    • Rectal cancer
    • Scleroderma
    • Inflammatory bowel disease
    • Small bowel obstruction
    • Congenital anorectal abnormalities
    • Grade 2 rectal prolapse
    • History of rectal resection 
    • Pelvic irradiation
  • Neurological disorders
    • Spinal cord injuries
    • Dementia (Mini-Mental status score <21)
    • 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 visit 
  • Currently pregnant or nursing
  • Prior history of intolerance to clonidine or colesevelam
  • Medications
    • Absolute- opioid analgesics
    • Relative- other antihypertensive agents (i.e. if there is concern about synergistic effects and hypotension)
    • Patients using drugs with anticholinergic effects will be excluded if they are used at high doses (e.g. nortriptyline greater than 50 mg/day or amitriptyline greater than 25 mg/day)
    • Patients who use lower doses will be eligible to participate provided the dose will be stable during the study 
• Phase 2
  • Positive urine pregnancy screen 
• Phase 3 (if any one is satisfied)
  • Missing data in bowel diaries, i.e. if patient did not record bowel symptoms data for more than 2 days in 1 week or 4 days over 2 weeks
  • Greater than 6 liquid [Bristol 6 or 7]) stools daily
  • Average of less than 1 bowel movement daily
  • Average Bristol stool score < 3 as assessed from analysis of bowel diaries
• Phase 4
  • Patients who completed less than 1 week of treatment with study drugs or placebo