Phase 3 N=56 Randomized Triple-blind Treatment

A Study of Colesevelam in Fecal Incontinence

Fecal Incontinence · Bile Acid Malabsorption

Bottom Line

View on ClinicalTrials.gov: NCT02628626 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2023

Primary outcome: Primary: Number of Participants to Report a 50% or Greater Reduction in Weekly Fecal Incontinence (FI) Episodes — 17; 13 Participants — p=0.85

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Colesevelam (Drug); Clonidine (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Mayo Clinic
Primary completion: Apr 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants to Report a 50% or Greater Reduction in Weekly Fecal Incontinence (FI) Episodes	17; 13	0.85
SECONDARY Daily Stool Frequency	2.4; 2.1	0.24
SECONDARY Stool Consistency	4.1; 3.2	0.44
SECONDARY Number of Semi-Formed Stools Per Week	1.0; 1.2	0.35
SECONDARY Delay of Bowel Movement	2.8; 3.6	0.56
SECONDARY Total Fecal Incontinence Episodes	4.2; 4.8	0.55
SECONDARY Volume of Fecal Incontinence	2.4; 3.3; 0.9; 2.0; 1.3; 2.4	0.11
SECONDARY Percent of Incontinent Bowel Movements Pre-treatment	45; 40	0.18
SECONDARY Percent of Incontinent Bowel Movements During Treatment	27; 28	0.04 sig
SECONDARY Percent of Incontinent Bowel Movements to be Semi-Formed Stools Pre-Treatment	61; 76	0.29
SECONDARY Percent of Incontinent Bowel Movements to be Semi-Formed Stools During Treatment	67; 61	0.39
SECONDARY Severity of Bowel Symptoms	6; 4.6	0.07
SECONDARY Severity of Fecal Incontinence	28; 22	0.12
SECONDARY Fecal Incontinence Quality of Life (FI-QoL)	2.7; 2.7; 2.0; 2.1; 3.1; 3.1	0.67
SECONDARY Loperamide Tablets Per Week	1.9; 6	0.78

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.

Eligibility Criteria

A. Phase 1

Inclusion Criteria

i) Females aged 18-80 years with urge predominant or combined (i.e. urge plus passive) FI, as defined by a validated questionnaire, for at least 1 year duration will be eligible to participate.

Exclusion Criteria

(i) History of clinically serious cardiovascular or pulmonary disease or EKG showing 2nd degree atrioventricular block or higher.

(ii) 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 or pelvic irradiation (iii) Neurological disorders - Spinal cord injuries, dementia (Mini-Mental status score <21), multiple sclerosis, Parkinson's disease, peripheral neuropathy (iv) Conditions precluding safe use of clonidine, i.e., symptomatic hypotension, or systolic blood pressure of <100 mm Hg on initial visit in Phase 1 of study (v) Currently pregnant or nursing women (vi) Prior history of intolerance to clonidine or colesevelam (vii) 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

B. Phase 2

Inclusion Criteria

i) Females aged 18-80 years with urge predominant or combined (i.e. urge plus passive) FI for at least 1 year, as defined by questionnaire

Exclusion criteria

(i) Positive urine pregnancy screen

C. Phase 3

Inclusion criteria

(i) 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 (ii) At least 1 episode of FI per week averaged over 2 weeks (iii) Average Bristol stool score of 3 or higher (iv) Average stool frequency of ≥1/day

Exclusion criteria (if at least one is satisfied):

(i) 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 (ii) Greater than 6 liquid [Bristol 6 or 7]) stools daily (iii) Average of less than 1 bowel movement daily (iv) Average Bristol stool score <3 as assessed from analysis of bowel diaries

D. Phase 4

Inclusion criteria

(i) All patients who complete at least 1 week of treatment with study drugs or placebo

Exclusion criteria

(i) Patients who completed less than 1 week of treatment with study drugs or placebo

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02628626). 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.