Study S001081

Efficacy of Liraglutide Therapy in Patients With an Ileal -Pouch Anal Anastomosis (IPAA) and Chronic High Bowel Frequency

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record Study Protocol and Statistical Analysis Plan (PDF)

Registration

Registration: NCT04763564
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: QUADRUPLE
Status: TERMINATED
Enrollment: 8
Start: 2022-03-22
Primary completion: 2023-10-16
Lead sponsor: University of North Carolina, Chapel Hill
Conditions: Pouchitis; Irritable Pouch Syndrome
Interventions: DRUG:Liraglutide Pen Injector; DRUG:Placebo Pen Injector
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1252-6589

Registered primary outcomes

Mean % Reduction of Bowel Frequency in Percent of the Mean 7-day Bowel Frequency After 4 Weeks of Therapy on Liraglutide vs Placebo Compared to Baseline . [Baseline, Week 4 (treatment period 1) and week 10 (treatment period 2)]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0009933	Efficacy and Safety of Liraglutide in Patients With an Ileal Pouch-Anal Anastomosis and Chronic High Bowel Frequency: A Placebo-Controlled, Crossover, Proof-of-Concept Study. Herfarth H, The American journal of gastroenterology	2024	Randomized trial	PMID 38668926 DOI	registry reference RESULT:38668926