A Study of Colesevelam in Fecal Incontinence

PHASE3CompletedINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

November 30, 2015

Primary Completion Date

April 14, 2022

Study Completion Date

April 14, 2022

Conditions
Fecal IncontinenceBile Acid Malabsorption
Interventions
DRUG

Colesevelam

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.

DRUG

Clonidine

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.

OTHER

Placebo

Placebo will be identical in appearance to the active drug.

Trial Locations (1)

55905

Mayo Clinic Rochester, Rochester

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

collaborator

National Center for Research Resources (NCRR)

NIH

lead

Mayo Clinic

OTHER