Status:
WITHDRAWN
Investigation of Eluxadoline for Diabetic Diarrhea
Lead Sponsor:
Temple University
Collaborating Sponsors:
Allergan
Conditions:
Diabetic Diarrhea
Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 g...
Detailed Description
Over 30 million Americans have been diagnosed with diabetes and the related complications account for the 7th most common cause of death in the United States. Within the gastrointestinal system, diabe...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Documented diabetes mellitus (DM) Type I or DM Type II - must be on medical therapy
- ≥ 3 bowel movements per day with Bristol type 6 or 7 stools at least 4 days per week for \> 6 months. They must continue to meet these criteria during the 4 week pre-randomization phase.
- Normal sigmoidoscopy or colonoscopy with biopsies negative for microscopic colitis
- Negative work up for Clostridium difficile
- Negative work up for Celiac Disease either by assessment of serum tissue transglutaminase Immunoglobulin A (IgA) or by small bowel biopsy
- Normal fecal elastase and fecal calprotectin levels
- Normal thryoid stimulating hormone (TSH) level
Exclusion
- Subjects who, in the estimation of the investigator, have drug-induced diarrhea
- Subjects unwilling to stop anti-diarrheal medications during the study
- Pregnancy or nursing mothers
- History of Cholecystectomy or Sphincter of Oddi Dysfunction
- Patients unable to undergo sigmoidoscopy or colonoscopy
- Patients with a history of inflammatory bowel disease (IBD)
- Prior history of pancreatitis
- Patients with hepatic impairment
- Patients who consume ≥ 3 alcoholic beverages per day
- Patients on oral opioids, who abuse illicit opioids, or have had a history of opioid abuse
- Patients on OATP1B1 Inhibitors (Rifampicin, Clarithromycin, Erythromycin, Cyclosporine, Gemfibrozil)
- Patients for whom inclusion in the study would be dangerous
- Subjects unable to consent
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04313088
Start Date
July 1 2022
End Date
December 1 2024
Last Update
May 6 2023
Active Locations (1)
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1
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140