Effects of Eluxadoline (Viberzi®) 100 mg Twice Daily on Diarrhea-Associated Fecal Incontinence
Status:
Withdrawn
Trial end date:
2020-03-01
Target enrollment:
Participant gender:
Summary
Accidental bowel leakage (fecal incontinence) increases in people who have diarrhea and
sensations of urgency to have a bowel movement. Drugs such as loperamide (Imodium) that
reduce diarrhea improve accidental bowel leakage, but loperamide has disadvantages: it is
difficult to find a dose that does not cause constipation, and it does not reduce urge
sensations. Eluxadoline is a new drug that is effective for reducing diarrhea, abdominal
pain, and urgency in patients with irritable bowel syndrome, and it may be less likely than
loperamide to cause severe constipation. Therefore, eluxadoline may help patients manage
accidental bowel leakage caused by diarrhea. The chemical name for Viberzi® is eluxadoline.
The primary aims of this study are to find out if eluxadoline at a dose of 100 mg orally
twice a day will reduce the average number of days the patient has accidental bowel leakage,
and to see if the rate of accidental bowel leakage increases when the patient stops taking
eluxadoline. Additional goals are to find out if eluxadoline decreases diarrhea and urge
sensations.
This is a small (pilot) study to show whether eluxadoline is an effective way of treating
accidental bowel leakage. If the study shows this, a larger study will be needed. There are
three phases to this 12-week study: (1) A two-week run-in period to see if the patient meets
the inclusion criteria. (2) Two months for treatment including one month on eluxadoline and
one on placebo (sugar pills) twice a day. (3) A two-week follow-up to see what happens when
you stop taking eluxadoline.
To participate in the study, patients should be aged 18 or older. Patients with inflammatory
bowel disease, anal fissures, or congenital malformations will be excluded.
The primary outcome is the average number of days per week with any solid or liquid bowel
accidents. Additional information includes: (1) Number of days per week the patient takes
loperamide, (2) days per week with loose or watery stools, (3) days per week with moderate to
strong urge sensations, and (4) questionnaires to measure the severity of accidental bowel
leakage, quality of life, anxiety, and depression. There will be up to 38 patients in the
study.