Fecal IncontinencePhase 2ELXDFINCT03489265
Effects of Eluxadoline (Viberzi®) 100 mg Twice Daily on Diarrhea-Associated Fecal Incontinence
A Phase 2 study testing Eluxadoline 100 mg in people with Fecal Incontinence and Accidental Bowel Leakage, run by University of North Carolina, Chapel Hill.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fecal Incontinence, Accidental Bowel Leakage, Anal Incontinence
- What is being tested?
- Eluxadoline 100 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2019to Mar 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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of solid or liquid FI and at least 4 BMs that are Bristol Stool types 6 or 7 during the first two weeks will be withdrawn from the study.
- Subjects who do not provide at least 4 days of valid stool diary data per week during the first two weeks will be withdrawn from the study.
About this study
Official title: Treatment of Diarrhea-Associated Fecal Incontinence With Eluxadoline
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.
Read more
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.
- Conditions
- Fecal Incontinence, Accidental Bowel Leakage, Anal Incontinence, Diarrhea, Urge Incontinence
- Being tested
- Eluxadoline 100 mg, Placebo
- Medical subject headings
- Fecal Incontinence, Encopresis, Diarrhea, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eluxadoline 100 mgDrug
Also called Viberzi®
100 mg capsule-shaped tablet by mouth taken twice per day
PlaceboOther
Also called sugar pill
Matching capsule-shaped placebo tablets taken by mouth twice per day
| Study group | Role | What they receive |
|---|---|---|
| Eluxadoline followed by Placebo | Other | 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. Receives: Drug: Eluxadoline 100 mg; Other: Placebo |
| Placebo followed by Eluxadoline | Other | 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. Receives: Drug: Eluxadoline 100 mg; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline Period, starting on Day 1 and ending at the conclusion of Day 14
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.
Measured: Treatment Period 1 (measured across Weeks 5 and 6)
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.
Measured: Treatment Period 2 (measured across Weeks 9 and 10)
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.
Measured: Follow-up period (measured across Weeks 11 and 12)
Secondary outcomes (12)
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.
Measured: Weeks 1, 2, 5, 6, 9, 10, 11, and 12
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.
Measured: Weeks 1, 2, 5, 6, 9, 10, 11, and 12
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.
Measured: Weeks 1, 2, 5, 6, 9, 10, 11, and 12
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.
Measured: Weeks 2, 6,10, and 12
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.
Measured: Weeks 2, 6, 10, and12
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.
Measured: Weeks 2, 6, 10, and 12
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.
Measured: Weeks 2, 6, 10, and 12
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.
Measured: Weeks 2, 6, 10, and 12
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.
Measured: Weeks 2, 6, 10, and 12
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.
Measured: Weeks 2, 6, 10, and 12
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.
Measured: Weeks 6, and 10
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.)
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study startApr 2019 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionMar 2020 (estimated)
Why it stopped: Difficult to recruit severely affected patients with fecal incontinence
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Sponsor
- Investigators
- William (Bill) Whitehead, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489265
- Sponsor's protocol ID
- 17-1561
- Other IDs
- 895
- Acronym
- ELXDFI
- Status last verified
- Jul 2019
- First submitted
- 9 Mar 2018
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 19410574Bharucha 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.
PubMed 16771954Lembo 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.
PubMed 26789872Simren M, Palsson OS, Heymen S, Bajor A, Tornblom H, Whitehead WE. Fecal incontinence in irritable bowel syndrome: Prevalence and associated factors in Swedish and American patients. Neurogastroenterol Motil. 2017 Feb;29(2):10.1111/nmo.12919. doi: 10.1111/nmo.12919. Epub 2016 Aug 31.
PubMed 27581702Sun WM, Read NW, Verlinden M. Effects of loperamide oxide on gastrointestinal transit time and anorectal function in patients with chronic diarrhoea and faecal incontinence. Scand J Gastroenterol. 1997 Jan;32(1):34-8. doi: 10.3109/00365529709025060.
PubMed 9018764Sjodahl 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.
PubMed 25892434Palmer KR, Corbett CL, Holdsworth CD. Double-blind cross-over study comparing loperamide, codeine and diphenoxylate in the treatment of chronic diarrhea. Gastroenterology. 1980 Dec;79(6):1272-5.
PubMed 7002706Dove LS, Lembo A, Randall CW, Fogel R, Andrae D, Davenport JM, McIntyre G, Almenoff JS, Covington PS. Eluxadoline benefits patients with irritable bowel syndrome with diarrhea in a phase 2 study. Gastroenterology. 2013 Aug;145(2):329-38.e1. doi: 10.1053/j.gastro.2013.04.006. Epub 2013 Apr 9.
PubMed 23583433Noelting J, Zinsmeister AR, Bharucha AE. Validating endpoints for therapeutic trials in fecal incontinence. Neurogastroenterol Motil. 2016 Aug;28(8):1148-56. doi: 10.1111/nmo.12809. Epub 2016 Mar 6.
PubMed 26948292Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7. doi: 10.1007/BF02237236.
PubMed 10813117Read M, Read NW, Barber DC, Duthie HL. Effects of loperamide on anal sphincter function in patients complaining of chronic diarrhea with fecal incontinence and urgency. Dig Dis Sci. 1982 Sep;27(9):807-14. doi: 10.1007/BF01391374.
PubMed 7105952
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Diarrhea-Associated Fecal Incontinence With Eluxadoline
- ClinicalTrials.gov ID
- NCT03489265
- Acronym / sponsor ID
- ELXDFI / 17-1561
- Conditions
- Fecal Incontinence, Accidental Bowel Leakage, Anal Incontinence, Diarrhea, Urge Incontinence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficult to recruit severely affected patients with fecal incontinence
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Apr 2019 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 5 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Eluxadoline followed by Placebo | Other | Drug: Eluxadoline 100 mg, Other: PlaceboFollowing 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. |
| Placebo followed by Eluxadoline | Other | Drug: Eluxadoline 100 mg, Other: PlaceboFollowing 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eluxadoline 100 mgAlso: Viberzi®100 mg capsule-shaped tablet by mouth taken twice per day | Drug | Eluxadoline followed by Placebo, Placebo followed by Eluxadoline |
| PlaceboAlso: sugar pillMatching capsule-shaped placebo tablets taken by mouth twice per day | Other | Eluxadoline followed by Placebo, Placebo followed by Eluxadoline |
Primary outcome
Run-in days per week with fecal incontinence
Time frame: Baseline Period, starting on Day 1 and ending at the conclusion of Day 14
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
Time frame: Treatment Period 1 (measured across Weeks 5 and 6)
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
Time frame: Treatment Period 2 (measured across Weeks 9 and 10)
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
Time frame: Follow-up period (measured across Weeks 11 and 12)
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.
12 secondary outcomes
Days per week with loperamide (escape medication)
Time frame: Weeks 1, 2, 5, 6, 9, 10, 11, and 12
Days per week patient described bowel movements as 6 or 7 on the Bristol Stool Scale
Time frame: Weeks 1, 2, 5, 6, 9, 10, 11, and 12
Days per week patient reported strong urge sensations
Time frame: Weeks 1, 2, 5, 6, 9, 10, 11, and 12
Fecal Incontinence Severity Score (FISS) over time
Time frame: Weeks 2, 6,10, and 12
Fecal Incontinence Quality of Life Scale Score for Lifestyle (FIQOL-Lifestyle)
Time frame: Weeks 2, 6, 10, and12
Fecal Incontinence Quality of Life Scale Score for Coping/Behavior (FIQOL-Coping/Behavior)
Time frame: Weeks 2, 6, 10, and 12
Fecal Incontinence Quality of Life Scale Score for Depression/Self-Perception (FIQOL-Depression/Self-Perception)
Time frame: Weeks 2, 6, 10, and 12
Fecal Incontinence Quality of Life Scale Score for Embarrassment (FIQOL-Embarrassment)
Time frame: Weeks 2, 6, 10, and 12
Brief Symptom Inventory-18 Anxiety Score (BSI-Anxiety)
Time frame: Weeks 2, 6, 10, and 12
Brief Symptom Inventory-18 Depression Score (BSI-Depression)
Time frame: Weeks 2, 6, 10, and 12
Preference for study drug vs. loperamide
Time frame: Weeks 6, and 10
Preference for eluxadoline or placebo
Time frame: Week 10
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
- Background: PubMed 19410574Whitehead 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.
- Background: PubMed 16771954Bharucha 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.
- Background: PubMed 26789872Lembo 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.
- Background: PubMed 27581702Simren M, Palsson OS, Heymen S, Bajor A, Tornblom H, Whitehead WE. Fecal incontinence in irritable bowel syndrome: Prevalence and associated factors in Swedish and American patients. Neurogastroenterol Motil. 2017 Feb;29(2):10.1111/nmo.12919. doi: 10.1111/nmo.12919. Epub 2016 Aug 31.
- Background: PubMed 9018764Sun WM, Read NW, Verlinden M. Effects of loperamide oxide on gastrointestinal transit time and anorectal function in patients with chronic diarrhoea and faecal incontinence. Scand J Gastroenterol. 1997 Jan;32(1):34-8. doi: 10.3109/00365529709025060.
- Background: PubMed 25892434Sjodahl 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.
- Background: PubMed 7002706Palmer KR, Corbett CL, Holdsworth CD. Double-blind cross-over study comparing loperamide, codeine and diphenoxylate in the treatment of chronic diarrhea. Gastroenterology. 1980 Dec;79(6):1272-5.
- Background: PubMed 23583433Dove LS, Lembo A, Randall CW, Fogel R, Andrae D, Davenport JM, McIntyre G, Almenoff JS, Covington PS. Eluxadoline benefits patients with irritable bowel syndrome with diarrhea in a phase 2 study. Gastroenterology. 2013 Aug;145(2):329-38.e1. doi: 10.1053/j.gastro.2013.04.006. Epub 2013 Apr 9.
- Background: PubMed 26948292Noelting J, Zinsmeister AR, Bharucha AE. Validating endpoints for therapeutic trials in fecal incontinence. Neurogastroenterol Motil. 2016 Aug;28(8):1148-56. doi: 10.1111/nmo.12809. Epub 2016 Mar 6.
- Background: PubMed 10813117Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7. doi: 10.1007/BF02237236.
- Background: PubMed 7105952Read M, Read NW, Barber DC, Duthie HL. Effects of loperamide on anal sphincter function in patients complaining of chronic diarrhea with fecal incontinence and urgency. Dig Dis Sci. 1982 Sep;27(9):807-14. doi: 10.1007/BF01391374.
- Link to Eluxadoline (Viberzi) Patient Information Guide and full prescribing information provided by AllerganLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William (Bill) Whitehead, PhD principal investigator
University of North Carolina, Chapel Hill
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eluxadoline 100 mg in people with Fecal Incontinence and Accidental Bowel Leakage, run by University of North Carolina, Chapel Hill.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Run-in days per week with fecal incontinence (time frame: Baseline Period, starting on Day 1 and ending at the conclusion of Day 14). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03489265, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2019.