Clinical trial NCT03489265: Effects of Eluxadoline (Viberzi®) 100 mg Twice Daily on Diarrhea-Associated Fecal Incontinence
Official title: Treatment of Diarrhea-Associated Fecal Incontinence With Eluxadoline
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Fecal Incontinence
Accidental Bowel Leakage
Anal Incontinence
Diarrhea
Urge Incontinence
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2018-04-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients will be randomized to 1 of 2 sequences. Each sequence includes 4 periods: Run-in, Treatment Period 1, Treatment Period 2, and Follow-Up. In Sequence A, Eluxadoline will be given 100 mg BID in Treatment Period 1 and Placebo will be given in Treatment Period 2. In Sequence B, Placebo will be given in Treatment Period 1 and Eluxadoline will be given in Treatment Period 2. Placebo will be given during Baseline and Follow-Up of both arms.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Run-in days per week with fecal incontinence
timeFrame: Baseline Period, starting on Day 1 and ending at the conclusion of Day 14
measure: Treatment Period 1 days per week with fecal incontinence
timeFrame: Treatment Period 1 (measured across Weeks 5 and 6)
measure: Treatment Period 2 days per week with fecal incontinence
timeFrame: Treatment Period 2 (measured across Weeks 9 and 10)
measure: Follow-up days per week with fecal incontinence
timeFrame: Follow-up period (measured across Weeks 11 and 12)
Secondary outcomes:
measure: Days per week with loperamide (escape medication)
timeFrame: Weeks 1, 2, 5, 6, 9, 10, 11, and 12
measure: Days per week patient described bowel movements as 6 or 7 on the Bristol Stool Scale
timeFrame: Weeks 1, 2, 5, 6, 9, 10, 11, and 12
measure: Days per week patient reported strong urge sensations
timeFrame: Weeks 1, 2, 5, 6, 9, 10, 11, and 12
measure: Fecal Incontinence Severity Score (FISS) over time
timeFrame: Weeks 2, 6,10, and 12
measure: Fecal Incontinence Quality of Life Scale Score for Lifestyle (FIQOL-Lifestyle)
timeFrame: Weeks 2, 6, 10, and12
measure: Fecal Incontinence Quality of Life Scale Score for Coping/Behavior (FIQOL-Coping/Behavior)
timeFrame: Weeks 2, 6, 10, and 12
measure: Fecal Incontinence Quality of Life Scale Score for Depression/Self-Perception (FIQOL-Depression/Self-Perception)
timeFrame: Weeks 2, 6, 10, and 12
measure: Fecal Incontinence Quality of Life Scale Score for Embarrassment (FIQOL-Embarrassment)
timeFrame: Weeks 2, 6, 10, and 12
measure: Brief Symptom Inventory-18 Anxiety Score (BSI-Anxiety)
timeFrame: Weeks 2, 6, 10, and 12
measure: Brief Symptom Inventory-18 Depression Score (BSI-Depression)
timeFrame: Weeks 2, 6, 10, and 12
measure: Preference for study drug vs. loperamide
timeFrame: Weeks 6, and 10
measure: Preference for eluxadoline or placebo
timeFrame: Week 10
Other outcomes:
Locations:
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: William (Bill) Whitehead, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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