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Double Blind, Placebo Controlled, Cross Over Study to Investigate the Effectiveness and Safety of Eluxadoline in the Treatment of Diabetic Diarrhea
Sponsor study identifier
interventional
0
1 country
1
Study Start
July 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Diabetes is a chronic disease that affects a large part of the United States population. The majority of patients with diabetes will experience gastrointestinal symptoms. One of the most troublesome gastrointestinal symptoms that diabetes can cause is diarrhea, otherwise known as "Diabetic Diarrhea." This occurs because diabetes does damage to nerves that control the gut and prevent it from functioning normally. Currently, there are only several medications used to treat the symptoms of Diabetic Diarrhea, but many of these medications have serious side effects or do not work well. We are investigating the drug eluxadoline for the treatment of Diabetic Diarrhea. Eluxadoline is a gut-specific medication that is FDA approved to treat diarrhea related to irritable bowel syndrome (IBS-D). Our hypothesis is eluxadoline will safely and successfully reduce diarrhea symptoms (number of stools and less liquid stools) and improve the quality of life in patients with Diabetic Diarrhea when compared with placebo. Each patient with Diabetic Diarrhea who participates will take both eluxadoline and a placebo drug at separate times over a period of several months as part of a crossover study design. While on each medication, eluxadoline or placebo, the participants will keep a diary of symptoms and will be followed by the medical team through a combination of office visits and questionnaires. There will be five planned office visits and intermittent phone calls (questionnaires, surveys) over the 140-day study period. Participants will not be permitted to use any other anti-diarrhea medication during the study period and will continue on medication for management of their diabetes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2024
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 16, 2020
Actual (reported)March 18, 2020
Actual (reported)July 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Proportion of days with improved bowel movements
Proportion of days in which all recorded bowel movements for that day have a consistency on the Bristol Stool Scale of \< 5. Scale: Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (easy to pass) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces, entirely liquid
140 days
Likert score for global satisfaction
140 days
Diabetes quality of life
140 days
Diarrhea quality of life
140 days
Fecal incontinence
140 days
Nocturnal diarrhea
140 days
All eligible patients will receive both eluxadoline and placebo, however each patient will be randomized to the order in which this happens. Eligible patients will be randomized 1:1 via random number generator to either receive eluxadoline 100mg twice daily then matching placebo or placebo then eluxadoline 100mg twice daily. Participants in Group A will take eluxadoline 100mg by mouth twice for 42 days. A washout phase will take place on days 43-70 where no study drug or placebo will be administered. On days 71-112, participants will crossover and take matching placebo by mouth twice daily. Each participant in Group A will take 42 days of eluxadoline 100mg twice daily followed by 42 days of placebo over the course the study.
All eligible patients will receive both eluxadoline and placebo, however each patient will be randomized to the order in which this happens. Eligible patients will be randomized 1:1 via random number generator to either receive eluxadoline 100mg twice daily then matching placebo or placebo then eluxadoline 100mg twice daily. Participants in Group B will take placebo by mouth twice daily for 42 days. A washout phase will take place on days 43-70 where no study drug or placebo will be administered. On days 71-112, participants will crossover and take eluxadoline 100mg by mouth twice daily. Each participant in Group B will take 42 days of placebo followed by 42 days of eluxadoline 100mg twice daily over the course the study.
Eluxadoline 100mg by mouth twice daily with food
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Gotfried J, Priest S, Schey R. Diabetes and the Small Intestine. Curr Treat Options Gastroenterol. 2017 Dec;15(4):490-507. doi: 10.1007/s11938-017-0155-x.
Mourad FH, Gorard D, Thillainayagam AV, Colin-Jones D, Farthing MJ. Effective treatment of diabetic diarrhoea with somatostatin analogue, octreotide. Gut. 1992 Nov;33(11):1578-80. doi: 10.1136/gut.33.11.1578.
Bytzer P, Talley NJ, Leemon M, Young LJ, Jones MP, Horowitz M. Prevalence of gastrointestinal symptoms associated with diabetes mellitus: a population-based survey of 15,000 adults. Arch Intern Med. 2001 Sep 10;161(16):1989-96. doi: 10.1001/archinte.161.16.1989.
Zachary Reichenbach, MD,PhD
Lewis Katz School of Medicine at Temple University
0 participants (actual enrollment reported by the registry).
Contact the study team to confirm eligibility.
Camilleri M, Malagelada JR. Abnormal intestinal motility in diabetics with the gastroparesis syndrome. Eur J Clin Invest. 1984 Dec;14(6):420-7. doi: 10.1111/j.1365-2362.1984.tb01206.x.
Yoneda S, Kadowaki M, Kuramoto H, Fukui H, Takaki M. Enhanced colonic peristalsis by impairment of nitrergic enteric neurons in spontaneously diabetic rats. Auton Neurosci. 2001 Sep 17;92(1-2):65-71. doi: 10.1016/S1566-0702(01)00317-4.
Yagihashi S, Sima AA. Diabetic autonomic neuropathy in BB rat. Ultrastructural and morphometric changes in parasympathetic nerves. Diabetes. 1986 Jul;35(7):733-43. doi: 10.2337/diab.35.7.733.
Yagihashi S, Sima AA. Neuroaxonal and dendritic dystrophy in diabetic autonomic neuropathy. Classification and topographic distribution in the BB-rat. J Neuropathol Exp Neurol. 1986 Sep;45(5):545-65. doi: 10.1097/00005072-198609000-00005.
Chandrasekharan B, Anitha M, Blatt R, Shahnavaz N, Kooby D, Staley C, Mwangi S, Jones DP, Sitaraman SV, Srinivasan S. Colonic motor dysfunction in human diabetes is associated with enteric neuronal loss and increased oxidative stress. Neurogastroenterol Motil. 2011 Feb;23(2):131-8, e26. doi: 10.1111/j.1365-2982.2010.01611.x. Epub 2010 Oct 12.
Yarandi SS, Srinivasan S. Diabetic gastrointestinal motility disorders and the role of enteric nervous system: current status and future directions. Neurogastroenterol Motil. 2014 May;26(5):611-24. doi: 10.1111/nmo.12330. Epub 2014 Mar 24.
D'Addio F, Fiorina P. Type 1 Diabetes and Dysfunctional Intestinal Homeostasis. Trends Endocrinol Metab. 2016 Jul;27(7):493-503. doi: 10.1016/j.tem.2016.04.005. Epub 2016 May 13.
Zanoni JN, Buttow NC, Bazotte RB, Miranda Neto MH. Evaluation of the population of NADPH-diaphorase-stained and myosin-V myenteric neurons in the ileum of chronically streptozotocin-diabetic rats treated with ascorbic acid. Auton Neurosci. 2003 Feb 28;104(1):32-8. doi: 10.1016/S1566-0702(02)00266-7.
Izbeki F, Wittman T, Rosztoczy A, Linke N, Bodi N, Fekete E, Bagyanszki M. Immediate insulin treatment prevents gut motility alterations and loss of nitrergic neurons in the ileum and colon of rats with streptozotocin-induced diabetes. Diabetes Res Clin Pract. 2008 May;80(2):192-8. doi: 10.1016/j.diabres.2007.12.013. Epub 2008 Feb 1.
Chang EB, Bergenstal RM, Field M. Diarrhea in streptozocin-treated rats. Loss of adrenergic regulation of intestinal fluid and electrolyte transport. J Clin Invest. 1985 May;75(5):1666-70. doi: 10.1172/JCI111874.
He CL, Soffer EE, Ferris CD, Walsh RM, Szurszewski JH, Farrugia G. Loss of interstitial cells of cajal and inhibitory innervation in insulin-dependent diabetes. Gastroenterology. 2001 Aug;121(2):427-34. doi: 10.1053/gast.2001.26264.
Luo P, Liu D, Li C, He WX, Zhang CL, Chang MJ. Enteric glial cell activation protects enteric neurons from damage due to diabetes in part via the promotion of neurotrophic factor release. Neurogastroenterol Motil. 2018 Oct;30(10):e13368. doi: 10.1111/nmo.13368. Epub 2018 May 8.
Fant RV, Henningfield JE, Cash BD, Dove LS, Covington PS. Eluxadoline Demonstrates a Lack of Abuse Potential in Phase 2 and 3 Studies of Patients With Irritable Bowel Syndrome With Diarrhea. Clin Gastroenterol Hepatol. 2017 Jul;15(7):1021-1029.e6. doi: 10.1016/j.cgh.2017.01.026. Epub 2017 Feb 3.
Munjal A, Dedania B, Cash B. Update on Pharmacotherapy for Irritable Bowel Syndrome. Curr Gastroenterol Rep. 2019 Apr 25;21(6):25. doi: 10.1007/s11894-019-0692-7.
Chen Y, Liu G, He F, Zhang L, Yang K, Yu H, Zhou J, Gan H. MicroRNA 375 modulates hyperglycemia-induced enteric glial cell apoptosis and Diabetes-induced gastrointestinal dysfunction by targeting Pdk1 and repressing PI3K/Akt pathway. Sci Rep. 2018 Aug 23;8(1):12681. doi: 10.1038/s41598-018-30714-0.
Bodi N, Szalai Z, Bagyanszki M. Nitrergic Enteric Neurons in Health and Disease-Focus on Animal Models. Int J Mol Sci. 2019 Apr 24;20(8):2003. doi: 10.3390/ijms20082003.
Selby A, Reichenbach ZW, Piech G, Friedenberg FK. Pathophysiology, Differential Diagnosis, and Treatment of Diabetic Diarrhea. Dig Dis Sci. 2019 Dec;64(12):3385-3393. doi: 10.1007/s10620-019-05846-6. No abstract available.
First Submitted
March 16, 2020
First Posted
March 18, 2020
Study Start
July 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 6, 2023
Record last verified: 2023-05
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