Status:
TERMINATED
Efficacy of Liraglutide Therapy in Patients With IPAA
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Pouchitis
Irritable Pouch Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Patients with an ileal pouch-anal anastomosis(IPAA; pouch) due to refractory inflammatory bowel disease and increased bowel frequency in the absence of significant pouch inflammation will be randomize...
Detailed Description
Randomized, double-blind, 2-period, placebo- controlled, crossover proof of concept study. Ten patients with increased bowel frequency defined as bowel frequency \> 8 bowel movements in 24 hours on a...
Eligibility Criteria
Inclusion
- Informed consent will be obtained before any trial-related procedures
- Age \> 18 years
- Patients with IPAA and bowel frequency \> 8 bowel movements in 24 hours on at least 4 of 7 days/week and presence of high bowel frequency \> 4 weeks despite adequate therapy for acute pouchitis or Crohn's like disease of the pouch
Exclusion
- Significant pouch inflammation defined as an endoscopic pouch disease activity index (PDAI ) ≥ 4
- Known stricture of the ileo-anal anastomosis or afferent limb stricture
- New onset of high bowel frequency in the setting of acute pouchitis
- IPAA since \< 6 months
- Known Clostridium difficile pouchitis
- Known clinically significant chronic nausea and/or vomiting in the past
- Known type 1 or type 2 diabetes
- History of or active neoplasia
- Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2
- Renal impairment defined as glomerular filtration rate (glomerular filtration rate \< 30)
- Clinically significant decompensated liver disease defined as elevation of aspartate aminotransferase , alanine transaminase or bilirubin \> 2-fold the upper limits of normal (Primary Sclerosing Cholangitis with liver function tests (LFT's) \<1.5 upper limits of normal can be included)
- New York Heart Association class 3 or greater heart failure or recent (within 6 months) cardiovascular event
- Prior history of pancreatitis
- Prior treatment with a GLP-1receptor agonist
- Known hypersensitivity to liraglutide or any product components
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
- Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening.
- Any disorder, which in the investigator's opinion might jeopardize patient's safety or compliance with the protocol.
Key Trial Info
Start Date :
March 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2023
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04763564
Start Date
March 22 2022
End Date
October 16 2023
Last Update
July 23 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of North Carolina
Chapel Hill, North Carolina, United States, 27599