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

Primary Purpose

Fecal Incontinence, Accidental Bowel Leakage, Anal Incontinence

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Eluxadoline 100 mg
Placebo
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fecal Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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of solid or liquid FI and at least 4 BMs that are Bristol Stool types 6 or 7 during the first two weeks will be withdrawn from the study.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 Subjects who do not provide at least 4 days of valid stool diary data per week during the first two weeks will be withdrawn from the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Eluxadoline followed by Placebo

    Placebo followed by Eluxadoline

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Run-in days per week with fecal incontinence
    If there are less than 5 days in a 7-day period that have complete diary data, the subject will be excluded. The number of days per week with fecal incontinence (i.e., a score >0) will be counted and divided by 7 to obtain a rate per week. The range of scores is 0 to 7 with 7 being the most severe fecal incontinence.
    Treatment Period 1 days per week with fecal incontinence
    If there are less than 5 days in a 7-day period that have complete diary data in weeks 5 and 6, the Treatment Period 1 variable will be missing. The number of days per week with fecal incontinence (i.e., a score >0) will be counted and divided by 7 to obtain a rate per week. The range of scores is 0 to 7 with 7 being the most severe fecal incontinence.
    Treatment Period 2 days per week with fecal incontinence
    If there are less than 5 days in a 7-day period that have complete diary data in weeks 9 and 10, the Treatment Period 2 variable is missing. The number of days per week with fecal incontinence (i.e., a score >0) will be counted and divided by 7 to obtain a rate per week. The range of scores is 0 to 7 with 7 being the most severe fecal incontinence.
    Follow-up days per week with fecal incontinence
    If there are less than 5 days in a 7-day period that have complete diary data in weeks 11 and 12, the Follow-Up variable is missing. The number of days per week with fecal incontinence (i.e., a score >0) will be counted and divided by 7 to obtain a rate per week. The range of scores is 0 to 7 with 7 being the most severe fecal incontinence.

    Secondary Outcome Measures

    Days per week with loperamide (escape medication)
    For eligibility analysis, Run-in (Weeks 1 and 2) will determine if there are 5 to 7 days in each week that can be evaluated; if less than one week, the subject is excluded. For treatment assessment, Treatment Period 1 (Weeks 5 and 6) and Treatment Period 2 (Weeks 9 and 10) will determine if there are 5 to 7 days that can be evaluated; if less than one week per period, the subject will be excluded from analysis. For evaluation of drug withdrawal, Follow-up (Weeks 11 and 12) will be examined to determine if there are 5 to 7 days that can be evaluated; if less than one week, the data is missing. In all analyses, count the number of days in each period with any loperamide used. The range of scores is 0 to 7 with 7 being the greatest amount of rescue medication used.
    Days per week patient described bowel movements as 6 or 7 on the Bristol Stool Scale
    For eligibility analysis, Run-in (Weeks 1 and 2) will determine if there are 5 to 7 days in each week that can be evaluated; if less than one week, the subject is excluded. For treatment assessment, Treatment Period 1 (Weeks 5 and 6) and Treatment Period 2 (Weeks 9 and 10) will determine if there are 5 to 7 days that can be evaluated; if less than one week per period, the subject will be excluded from analysis. For evaluation of drug withdrawal, Follow-up (Weeks 11 and 12) will be examined to determine if there are 5 to 7 days that can be evaluated; if less than one week, the data is missing. In all analyses, count the number of days in each period with any Bristol Stool Scale score of 6 or 7. The range of scores is 0 to 7 days with 7 being the most severe diarrhea.
    Days per week patient reported strong urge sensations
    For eligibility analysis, Run-in (Weeks 1 and 2) will determine if there are 5 to 7 days in each week that can be evaluated; if less than one week, the subject is excluded. For treatment assessment, Treatment Period 1 (Weeks 5 and 6) and Treatment Period 2 (Weeks 9 and 10) will determine if there are 5 to 7 days that can be evaluated; if less than one week per period, the subject will be excluded from analysis. For evaluation of drug withdrawal, Follow-up (Weeks 11 and 12) will be examined to determine if there are 5 to 7 days that can be evaluated; if less than one week, the data is missing. In all analyses, count the number of days in each period with any moderate to strong urge sensations . The range of scores is 0 to 7 days with 7 being the most severe urgency to defecate.
    Fecal Incontinence Severity Score (FISS) over time
    For clinic visits in Weeks 2, 6, 10, and 12, compute the score for the 4 components of the FISS. These components are frequency of leaks, type of leakage, amount that leaked, and urgency vs. passive incontinence. These individual items are added together to form a total score which ranges from 3 to 13, with 13 representing the most severe form of fecal incontinence (FI). If items are not completed or are not correct, the FISS score is missing.
    Fecal Incontinence Quality of Life Scale Score for Lifestyle (FIQOL-Lifestyle)
    For clinic visits in Weeks 2, 6, 10, and 12, compute the scale score for lifestyle. If more than half of the items in the scale are present, the score is based on the average for those items; otherwise the FIQOL-Lifestyle scale score is missing. Scores range from 0 to 4 with 4 representing the greatest impairment in FIQOL-Lifestyle.
    Fecal Incontinence Quality of Life Scale Score for Coping/Behavior (FIQOL-Coping/Behavior)
    For clinic visits in Weeks 2, 6, 10, and 12, compute the scale score for Coping/Behavior. If more than half of the items in the scale are present, the score is based on the average for those items; otherwise the FIQOL-Coping/Behavior scale score is missing. Scores range from 0 to 4 with 4 representing the greatest impairment in FIQOL-Coping/Behavior.
    Fecal Incontinence Quality of Life Scale Score for Depression/Self-Perception (FIQOL-Depression/Self-Perception)
    For clinic visits in Weeks 2, 6, 10, and 12, compute the scale score for Depression/Self-Perception. If more than half of the items in the scale are present, the score is based on the average for those items; otherwise the FIQOL-Depression/Self-Perception scale score is missing. Scores range from 0 to 4 with 4 representing the greatest impairment in FIQOL-Depression/Self-Perception.
    Fecal Incontinence Quality of Life Scale Score for Embarrassment (FIQOL-Embarrassment)
    For clinic visits in Weeks 2, 6, 10, and 12, compute the scale score for Embarrassment. If more than half of the items in the scale are present, the score is based on the average for those items; otherwise the FIQOL-Embarrassment scale score is missing. Scores range from 0 to 4 with 4 representing the greatest impairment in FIQOL-Embarrassment.
    Brief Symptom Inventory-18 Anxiety Score (BSI-Anxiety)
    For each visit to the clinic, compute the previous week's BSI scores for anxiety. If more than two items are not answered, the score is not valid. Scores of 0 to 4 are added across items with missing items being replaced by the average for the present items, and the summary score is transformed into a T-score in which the average score is 50 and 10 is equivalent to a standard deviation in the reference sample. A score of 60 represents one standard deviation above the population mean for severity of anxiety.
    Brief Symptom Inventory-18 Depression Score (BSI-Depression)
    For each visit to the clinic, compute the previous week's BSI scores for depression. If more than two items are not answered, the score is not valid. Scores of 0 to 4 are added across items with missing items being replaced by the average for the present items, and the summary score is transformed into a T-score in which the average score is 50 and 10 is equivalent to a standard deviation in the reference sample. A score of 60 represents one standard deviation above the population mean for severity of depression.
    Preference for study drug vs. loperamide
    On Week 6 and 10, subject will be asked to compare the study drug to loperamide for the previous 4 weeks. The choices are -2=strongly prefer loperamide, -1=somewhat prefer loperamide, 0=no preference, 1=somewhat prefer study drug, and 2=strongly prefer study drug. The range of scores is -2 to +2, with +2 being equivalent to a strong preference for the study drug over loperamide.
    Preference for eluxadoline or placebo
    At week 10, subjects will be asked to compare the second study drug to the first study drug for the previous 8 weeks. For subjects randomized to the "Eluxadoline followed by Placebo" group, the first study drug is eluxadoline; for subjects in the "Placebo followed by Eluxadoline" group the second study drug is eluxadoline. To estimate the preference of subjects for eluxadoline, the preference of the first group for the first study period and the preferences of the second group for the second study period will be averaged. The range of outcome scores is -2 to +2 with +2 representing a strong preference for eluxadoline over placebo. (The excluded groups are available as a way to assess whether order effects interfere with the measurement of preferences for eluxadoline vs. placebo.)

    Full Information

    First Posted
    March 9, 2018
    Last Updated
    July 23, 2019
    Sponsor
    University of North Carolina, Chapel Hill
    Collaborators
    Allergan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03489265
    Brief Title
    Effects of Eluxadoline (Viberzi®) 100 mg Twice Daily on Diarrhea-Associated Fecal Incontinence
    Acronym
    ELXDFI
    Official Title
    Treatment of Diarrhea-Associated Fecal Incontinence With Eluxadoline
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Difficult to recruit severely affected patients with fecal incontinence
    Study Start Date
    April 2019 (Anticipated)
    Primary Completion Date
    September 2019 (Anticipated)
    Study Completion Date
    March 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of North Carolina, Chapel Hill
    Collaborators
    Allergan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fecal Incontinence, Accidental Bowel Leakage, Anal Incontinence, Diarrhea, Urge Incontinence

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    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.
    Masking
    ParticipantCare ProviderInvestigator
    Masking Description
    Patients will not be aware when Eluxadoline or Placebo are administered. Investigators will be masked to whether Eluxadoline is given in Treatment Period 1 or Treatment Period 2 unless there is an adverse event that requires unmasking the treatment for this patient to ascertain whether the adverse event is drug-related.
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Eluxadoline followed by Placebo
    Arm Type
    Other
    Arm 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.
    Arm Title
    Placebo followed by Eluxadoline
    Arm Type
    Other
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Eluxadoline 100 mg
    Other Intervention Name(s)
    Viberzi®
    Intervention Description
    100 mg capsule-shaped tablet by mouth taken twice per day
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    sugar pill
    Intervention Description
    Matching capsule-shaped placebo tablets taken by mouth twice per day
    Primary Outcome Measure Information:
    Title
    Run-in days per week with fecal incontinence
    Description
    If there are less than 5 days in a 7-day period that have complete diary data, the subject will be excluded. The number of days per week with fecal incontinence (i.e., a score >0) will be counted and divided by 7 to obtain a rate per week. The range of scores is 0 to 7 with 7 being the most severe fecal incontinence.
    Time Frame
    Baseline Period, starting on Day 1 and ending at the conclusion of Day 14
    Title
    Treatment Period 1 days per week with fecal incontinence
    Description
    If there are less than 5 days in a 7-day period that have complete diary data in weeks 5 and 6, the Treatment Period 1 variable will be missing. The number of days per week with fecal incontinence (i.e., a score >0) will be counted and divided by 7 to obtain a rate per week. The range of scores is 0 to 7 with 7 being the most severe fecal incontinence.
    Time Frame
    Treatment Period 1 (measured across Weeks 5 and 6)
    Title
    Treatment Period 2 days per week with fecal incontinence
    Description
    If there are less than 5 days in a 7-day period that have complete diary data in weeks 9 and 10, the Treatment Period 2 variable is missing. The number of days per week with fecal incontinence (i.e., a score >0) will be counted and divided by 7 to obtain a rate per week. The range of scores is 0 to 7 with 7 being the most severe fecal incontinence.
    Time Frame
    Treatment Period 2 (measured across Weeks 9 and 10)
    Title
    Follow-up days per week with fecal incontinence
    Description
    If there are less than 5 days in a 7-day period that have complete diary data in weeks 11 and 12, the Follow-Up variable is missing. The number of days per week with fecal incontinence (i.e., a score >0) will be counted and divided by 7 to obtain a rate per week. The range of scores is 0 to 7 with 7 being the most severe fecal incontinence.
    Time Frame
    Follow-up period (measured across Weeks 11 and 12)
    Secondary Outcome Measure Information:
    Title
    Days per week with loperamide (escape medication)
    Description
    For eligibility analysis, Run-in (Weeks 1 and 2) will determine if there are 5 to 7 days in each week that can be evaluated; if less than one week, the subject is excluded. For treatment assessment, Treatment Period 1 (Weeks 5 and 6) and Treatment Period 2 (Weeks 9 and 10) will determine if there are 5 to 7 days that can be evaluated; if less than one week per period, the subject will be excluded from analysis. For evaluation of drug withdrawal, Follow-up (Weeks 11 and 12) will be examined to determine if there are 5 to 7 days that can be evaluated; if less than one week, the data is missing. In all analyses, count the number of days in each period with any loperamide used. The range of scores is 0 to 7 with 7 being the greatest amount of rescue medication used.
    Time Frame
    Weeks 1, 2, 5, 6, 9, 10, 11, and 12
    Title
    Days per week patient described bowel movements as 6 or 7 on the Bristol Stool Scale
    Description
    For eligibility analysis, Run-in (Weeks 1 and 2) will determine if there are 5 to 7 days in each week that can be evaluated; if less than one week, the subject is excluded. For treatment assessment, Treatment Period 1 (Weeks 5 and 6) and Treatment Period 2 (Weeks 9 and 10) will determine if there are 5 to 7 days that can be evaluated; if less than one week per period, the subject will be excluded from analysis. For evaluation of drug withdrawal, Follow-up (Weeks 11 and 12) will be examined to determine if there are 5 to 7 days that can be evaluated; if less than one week, the data is missing. In all analyses, count the number of days in each period with any Bristol Stool Scale score of 6 or 7. The range of scores is 0 to 7 days with 7 being the most severe diarrhea.
    Time Frame
    Weeks 1, 2, 5, 6, 9, 10, 11, and 12
    Title
    Days per week patient reported strong urge sensations
    Description
    For eligibility analysis, Run-in (Weeks 1 and 2) will determine if there are 5 to 7 days in each week that can be evaluated; if less than one week, the subject is excluded. For treatment assessment, Treatment Period 1 (Weeks 5 and 6) and Treatment Period 2 (Weeks 9 and 10) will determine if there are 5 to 7 days that can be evaluated; if less than one week per period, the subject will be excluded from analysis. For evaluation of drug withdrawal, Follow-up (Weeks 11 and 12) will be examined to determine if there are 5 to 7 days that can be evaluated; if less than one week, the data is missing. In all analyses, count the number of days in each period with any moderate to strong urge sensations . The range of scores is 0 to 7 days with 7 being the most severe urgency to defecate.
    Time Frame
    Weeks 1, 2, 5, 6, 9, 10, 11, and 12
    Title
    Fecal Incontinence Severity Score (FISS) over time
    Description
    For clinic visits in Weeks 2, 6, 10, and 12, compute the score for the 4 components of the FISS. These components are frequency of leaks, type of leakage, amount that leaked, and urgency vs. passive incontinence. These individual items are added together to form a total score which ranges from 3 to 13, with 13 representing the most severe form of fecal incontinence (FI). If items are not completed or are not correct, the FISS score is missing.
    Time Frame
    Weeks 2, 6,10, and 12
    Title
    Fecal Incontinence Quality of Life Scale Score for Lifestyle (FIQOL-Lifestyle)
    Description
    For clinic visits in Weeks 2, 6, 10, and 12, compute the scale score for lifestyle. If more than half of the items in the scale are present, the score is based on the average for those items; otherwise the FIQOL-Lifestyle scale score is missing. Scores range from 0 to 4 with 4 representing the greatest impairment in FIQOL-Lifestyle.
    Time Frame
    Weeks 2, 6, 10, and12
    Title
    Fecal Incontinence Quality of Life Scale Score for Coping/Behavior (FIQOL-Coping/Behavior)
    Description
    For clinic visits in Weeks 2, 6, 10, and 12, compute the scale score for Coping/Behavior. If more than half of the items in the scale are present, the score is based on the average for those items; otherwise the FIQOL-Coping/Behavior scale score is missing. Scores range from 0 to 4 with 4 representing the greatest impairment in FIQOL-Coping/Behavior.
    Time Frame
    Weeks 2, 6, 10, and 12
    Title
    Fecal Incontinence Quality of Life Scale Score for Depression/Self-Perception (FIQOL-Depression/Self-Perception)
    Description
    For clinic visits in Weeks 2, 6, 10, and 12, compute the scale score for Depression/Self-Perception. If more than half of the items in the scale are present, the score is based on the average for those items; otherwise the FIQOL-Depression/Self-Perception scale score is missing. Scores range from 0 to 4 with 4 representing the greatest impairment in FIQOL-Depression/Self-Perception.
    Time Frame
    Weeks 2, 6, 10, and 12
    Title
    Fecal Incontinence Quality of Life Scale Score for Embarrassment (FIQOL-Embarrassment)
    Description
    For clinic visits in Weeks 2, 6, 10, and 12, compute the scale score for Embarrassment. If more than half of the items in the scale are present, the score is based on the average for those items; otherwise the FIQOL-Embarrassment scale score is missing. Scores range from 0 to 4 with 4 representing the greatest impairment in FIQOL-Embarrassment.
    Time Frame
    Weeks 2, 6, 10, and 12
    Title
    Brief Symptom Inventory-18 Anxiety Score (BSI-Anxiety)
    Description
    For each visit to the clinic, compute the previous week's BSI scores for anxiety. If more than two items are not answered, the score is not valid. Scores of 0 to 4 are added across items with missing items being replaced by the average for the present items, and the summary score is transformed into a T-score in which the average score is 50 and 10 is equivalent to a standard deviation in the reference sample. A score of 60 represents one standard deviation above the population mean for severity of anxiety.
    Time Frame
    Weeks 2, 6, 10, and 12
    Title
    Brief Symptom Inventory-18 Depression Score (BSI-Depression)
    Description
    For each visit to the clinic, compute the previous week's BSI scores for depression. If more than two items are not answered, the score is not valid. Scores of 0 to 4 are added across items with missing items being replaced by the average for the present items, and the summary score is transformed into a T-score in which the average score is 50 and 10 is equivalent to a standard deviation in the reference sample. A score of 60 represents one standard deviation above the population mean for severity of depression.
    Time Frame
    Weeks 2, 6, 10, and 12
    Title
    Preference for study drug vs. loperamide
    Description
    On Week 6 and 10, subject will be asked to compare the study drug to loperamide for the previous 4 weeks. The choices are -2=strongly prefer loperamide, -1=somewhat prefer loperamide, 0=no preference, 1=somewhat prefer study drug, and 2=strongly prefer study drug. The range of scores is -2 to +2, with +2 being equivalent to a strong preference for the study drug over loperamide.
    Time Frame
    Weeks 6, and 10
    Title
    Preference for eluxadoline or placebo
    Description
    At week 10, subjects will be asked to compare the second study drug to the first study drug for the previous 8 weeks. For subjects randomized to the "Eluxadoline followed by Placebo" group, the first study drug is eluxadoline; for subjects in the "Placebo followed by Eluxadoline" group the second study drug is eluxadoline. To estimate the preference of subjects for eluxadoline, the preference of the first group for the first study period and the preferences of the second group for the second study period will be averaged. The range of outcome scores is -2 to +2 with +2 representing a strong preference for eluxadoline over placebo. (The excluded groups are available as a way to assess whether order effects interfere with the measurement of preferences for eluxadoline vs. placebo.)
    Time Frame
    Week 10

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: At least 18 years of age. Any gender, race, or ethnicity. Must self-report an average of at least 2 episodes of solid or liquid FI per week for the previous month. 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). Subjects must have access to the internet at home and be willing to enter symptom data each night before sleeping. Exclusion Criteria: Patients with inflammatory bowel disease, anal fissure, or congenital malformations as a cause of FI will be excluded. 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. 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    William (Bill) Whitehead, PhD
    Organizational Affiliation
    University of North Carolina, Chapel Hill
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB) and executes a data use/sharing agreement with the University of North Carolina.
    IPD Sharing Time Frame
    9-36 months following publication of the study results.
    IPD Sharing Access Criteria
    Requester must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IED), or Research Ethics Board (REB), and requester has executed an acceptable data use/sharing agreement with UNC.
    IPD Sharing URL
    https://irbis2.research.unc.edu/irb/
    Citations:
    PubMed Identifier
    19410574
    Citation
    Whitehead WE, Borrud L, Goode PS, Meikle S, Mueller ER, Tuteja A, Weidner A, Weinstein M, Ye W; Pelvic Floor Disorders Network. Fecal incontinence in US adults: epidemiology and risk factors. Gastroenterology. 2009 Aug;137(2):512-7, 517.e1-2. doi: 10.1053/j.gastro.2009.04.054. Epub 2009 May 4.
    Results Reference
    background
    PubMed Identifier
    16771954
    Citation
    Bharucha AE, Zinsmeister AR, Locke GR, Seide BM, McKeon K, Schleck CD, Melton LJ 3rd. Risk factors for fecal incontinence: a population-based study in women. Am J Gastroenterol. 2006 Jun;101(6):1305-12. doi: 10.1111/j.1572-0241.2006.00553.x.
    Results Reference
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    PubMed Identifier
    26789872
    Citation
    Lembo AJ, Lacy BE, Zuckerman MJ, Schey R, Dove LS, Andrae DA, Davenport JM, McIntyre G, Lopez R, Turner L, Covington PS. Eluxadoline for Irritable Bowel Syndrome with Diarrhea. N Engl J Med. 2016 Jan 21;374(3):242-53. doi: 10.1056/NEJMoa1505180.
    Results Reference
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    PubMed Identifier
    27581702
    Citation
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    Citation
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    Citation
    Sjodahl J, Walter SA, Johansson E, Ingemansson A, Ryn AK, Hallbook O. Combination therapy with biofeedback, loperamide, and stool-bulking agents is effective for the treatment of fecal incontinence in women - a randomized controlled trial. Scand J Gastroenterol. 2015 Aug;50(8):965-74. doi: 10.3109/00365521.2014.999252. Epub 2015 Apr 20.
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    Links:
    URL
    http://www.allergan.com/assets/pdf/viberzi_pi
    Description
    Link to Eluxadoline (Viberzi) Patient Information Guide and full prescribing information provided by Allergan

    Learn more about this trial

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

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