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Mu-opioid Receptor Agonist

Experimental Group A for Diabetic Diarrhea

Phase 2 & 3

Waitlist Available

Led By Frank Friedenberg, MD

Research Sponsored by Temple University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 140 days

Awards & highlights

Study Summary

This trial is investigating whether or not the drug eluxadoline is effective in reducing symptoms of diarrhea for patients with diabetes. The trial will last 140 days, during which patients will take either eluxadoline or a placebo drug, and keep a diary of their symptoms.

Eligible Conditions

Diabetic Diarrhea
Diabetes
Diarrhea

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 140 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~140 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 140 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Defecation

Secondary outcome measures

Diabetes quality of life

Diarrhea quality of life

Fecal Incontinence

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Experimental Group BExperimental Treatment1 Intervention

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.

Group II: Experimental Group AExperimental Treatment1 Intervention

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.

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Who is running the clinical trial?

Temple UniversityLead Sponsor

297 Previous Clinical Trials

82,973 Total Patients Enrolled

AllerganIndustry Sponsor

781 Previous Clinical Trials

276,569 Total Patients Enrolled

Frank Friedenberg, MDPrincipal InvestigatorTemple University Hospital

1 Previous Clinical Trials

136 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you walk me through the other research that has been done on this therapy?

"There are currently 3 ongoing clinical trials evaluating this intervention, 2 of which are Phase 3 trials. Most of these studies are based in Cleveland, Ohio; however, there are 130 clinical trial sites in total."

Answered by AI

Is this study still recruiting new participants?

"Unfortunately, this particular trial is not presently looking for new patients. The most recent update on the study was on February 15th, 2022. Even though this study isn't taking any more candidates, there are still 260 other trials that are."

Answered by AI

What are the origins of this research?

"Allergan's 2017 clinical trial, which involved 120 patients and completed Phase 2 drug approval, was the first of its kind. As of now, there are 3 ongoing trials for this treatment across 50 cities and 12 countries. In the 5 years since Allergan's study,"

Answered by AI

Recent research and studies

Trends in Endocrinology & MetabolismJournal

Type 1 Diabetes and Dysfunctional Intestinal Homeostasis

D’Addio, Francesca, and Paolo Fiorina. 2016. “Type 1 Diabetes and Dysfunctional Intestinal Homeostasis”. Trends in Endocrinology & Metabolism. Elsevier BV. doi:10.1016/j.tem.2016.04.005.

Archives of Internal MedicineJournal

Prevalence of Gastrointestinal Symptoms Associated with Diabetes Mellitus

Bytzer, Peter, Nicholas J. Talley, Melanie Leemon, Lisa J. Young, Michael P. Jones, and Michael Horowitz. 2001. “Prevalence of Gastrointestinal Symptoms Associated with Diabetes Mellitus”. Archives of Internal Medicine. American Medical Association (AMA). doi:10.1001/archinte.161.16.1989.

Neurogastroenterology & MotilityJournal

Colonic Motor Dysfunction in Human Diabetes Is Associated with Enteric Neuronal Loss and Increased Oxidative Stress

Chandrasekharan, B., M. Anitha, R. Blatt, N. Shahnavaz, D. Kooby, C. Staley, S. Mwangi, D. P. Jones, S. V. Sitaraman, and S. Srinivasan. 2010. “Colonic Motor Dysfunction in Human Diabetes Is Associated with Enteric Neuronal Loss and Increased Oxidative Stress”. Neurogastroenterology & Motility. Wiley. doi:10.1111/j.1365-2982.2010.01611.x.

Journal of Clinical InvestigationJournal