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Liraglutide for High Bowel Frequency in IPAA
NCT04763564Phase 2
Key facts
- Status
- Terminated
- Start
- Mar 2022
- Primary completion
- Oct 2023
- Countries
- 1
- Sponsor
- University of North Carolina at Chapel Hill
- Modality
- Peptides
- Drugs
- liraglutide
- Conditions
- irritable pouch syndrome (IPS)
01
Overview
Phase 2, randomised, double-blind trial of liraglutide in irritable pouch syndrome (IPS) (2 arms), sponsored by University of North Carolina at Chapel Hill. Primary endpoint: Mean % Reduction of Bowel Frequency in Percent of the Mean 7-day Bowel Frequency After 4 Weeks of Therapy. Started Mar 2022; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Liraglutide then Placebo
Liraglutide in Period 1, then Placebo in Period 2
Placebo then Liraglutide
Placebo in Period 1, then Liraglutide in Period 2
03
Who it enrols
Adult patients with IPAA and chronic high bowel frequency (>8/day) despite adequate therapy, without significant pouch inflammation or diabetes.
04
Endpoints
Primary
Mean % Reduction of Bowel Frequency in Percent of the Mean 7-day Bowel Frequency After 4 Weeks of Therapy
Secondary
Change in the 7 Day Mean Number of Day and Night Bowel Frequency
Discontinuation of Therapy in Each Treatment Arm
Mean % Reduction of Bowel Frequency in Percent of the Mean 7-day Bowel Frequency After 6 Weeks of Therapy
05
Results
Primary endpoints met
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