Effects of Eluxadoline (Viberzi®) 100 mg Twice Daily on Diarrhea-Associated Fecal Incontinence (ELXDFI)

University of North Carolina (UNC)

Status and phase: Withdrawn; Phase 2

Conditions: Accidental Bowel Leakage; Anal Incontinence; Diarrhea; Fecal Incontinence; Urge Incontinence

Treatments: Other: Placebo; Drug: Eluxadoline 100 mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03489265

895 (Other Grant/Funding Number)

17-1561

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. At least 18 years of age.
2. Any gender, race, or ethnicity.
3. Must self-report an average of at least 2 episodes of solid or liquid FI per week for the previous month.
4. Must self-report an average of at least 2 bowel movements (BMs) per week that are Bristol Types 6 or 7 (mushy or liquid stools).
5. Subjects must have access to the internet at home and be willing to enter symptom data each night before sleeping.

Exclusion criteria

1. Patients with inflammatory bowel disease, anal fissure, or congenital malformations as a cause of FI will be excluded.
2. Subjects who start the study and do not experience at least 4 episodes of solid or liquid FI and at least 4 BMs that are Bristol Stool types 6 or 7 during the first two weeks will be withdrawn from the study.
3. Subjects who do not provide at least 4 days of valid stool diary data per week during the first two weeks will be withdrawn from the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Eluxadoline followed by Placebo

Other group

Description:

Following a 2-week run-in period, patients will receive Eluxadoline 100 mg twice daily for 4 weeks then placebo tablets taken twice daily for 4 weeks followed by a 2-week follow-up period during which placebo will be administered twice daily.

Treatment:

Drug: Eluxadoline 100 mg

Other: Placebo

Placebo followed by Eluxadoline

Other group

Description:

Following a 2-week run-in period, patients will receive placebo twice daily for 4 weeks then Eluxadoline 100 mg twice daily for 4 weeks followed by a 2-week follow-up period during which placebo will be administered twice daily.

Treatment:

Drug: Eluxadoline 100 mg

Other: Placebo