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Difficult to recruit severely affected patients with fecal incontinence
ELXDFI
Treatment of Diarrhea-Associated Fecal Incontinence With Eluxadoline
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Allergan Pharmaceutical
interventional
0
0 countries
N/A
Study Start
April 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 9, 2018
Actual (reported)April 5, 2018
Actual (reported)April 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
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.
Treatment Period 1 (measured across Weeks 5 and 6)
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.
100 mg capsule-shaped tablet by mouth taken twice per day
Matching capsule-shaped placebo tablets taken by mouth twice per day
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.
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.
William (Bill) Whitehead, PhD
University of North Carolina, Chapel Hill
0 participants (actual enrollment reported by the registry).
First Submitted
March 9, 2018
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.
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.
Follow-up period (measured across Weeks 11 and 12)
Days per week with loperamide (escape medication)
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
Weeks 1, 2, 5, 6, 9, 10, 11, and 12
Days per week patient reported strong urge sensations
Weeks 1, 2, 5, 6, 9, 10, 11, and 12
Fecal Incontinence Severity Score (FISS) over time
Weeks 2, 6,10, and 12
Fecal Incontinence Quality of Life Scale Score for Lifestyle (FIQOL-Lifestyle)
Weeks 2, 6, 10, and12
Contact the study team to confirm eligibility.
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.
Simren 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.
Sun 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.
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.
Palmer 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.
Dove 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.
Noelting 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.
Rockwood 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.
Read 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.
First Posted
April 5, 2018
Study Start
April 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 25, 2019
Record last verified: 2019-07
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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Source: ClinicalTrials.gov.
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