A Study of Colesevelam in Fecal Incontinence

NCT02628626 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: 15-005986R01DK078924UL1RR024150
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fecal Incontinence; Bile Acid Malabsorption

Keywords

Incontinence; Diarrhea; Bile acid; Microbiome

Outcome Measures

Primary Outcomes (1)

• Number of Participants to Report a 50% or Greater Reduction in Weekly Fecal Incontinence (FI) Episodes

  The number of participants that report a 50% or greater reduction in weekly incontinent episodes as measured by self-reported bowel diaries.

  4 weeks

Secondary Outcomes (14)

• Daily Stool Frequency

  4 weeks

• Stool Consistency

  4 weeks

• Number of Semi-Formed Stools Per Week

  4 weeks

• Delay of Bowel Movement

  4 weeks

• Total Fecal Incontinence Episodes

  4 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants in this arm will receive placebo for 4 weeks.

Other: Placebo

Colesevelam and Clonidine

ACTIVE COMPARATOR

Participants in this arm will receive a combination of colesevelam (1.875 gm twice daily) and clonidine (0.1 mg oral twice daily) for 4 weeks.

Drug: Colesevelam; Drug: Clonidine

Interventions

Colesevelam DRUG

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.

Also known as: Welchol

Colesevelam and Clonidine

Clonidine DRUG

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.

Also known as: Catapres

Colesevelam and Clonidine

Placebo OTHER

Placebo will be identical in appearance to the active drug.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• (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
• 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
• (i) Positive urine pregnancy screen
• C. Phase 3
• (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
• (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
• (i) All patients who complete at least 1 week of treatment with study drugs or placebo
• (i) Patients who completed less than 1 week of treatment with study drugs or placebo

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Fecal Incontinence; Diarrhea

Interventions

Colesevelam Hydrochloride; Clonidine

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Allylamine; Amines; Organic Chemicals; Allyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Adil Bharucha
• Organization: Mayo Clinic

bharucha.adil@mayo.edu

507-284-2687

Study Officials

• Adil Bharucha, MBBS, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 11, 2015
• Study Start: November 1, 2015
• Primary Completion: April 14, 2022
• Study Completion: April 14, 2022
• Last Updated: June 22, 2023
• Results First Posted: June 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)