Efficacy of Liraglutide Therapy in Patients With IPAA

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT04763564
Phase
PHASE2
Status
Terminated

Conditions

  • Irritable Pouch Syndrome
  • Pouchitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide Pen Injector — DRUG
    Treatment will be initiated at 0.6 mg per day for one week. The patient will be instructed to increase the dose to 1.2/day and 1.8 mg /day in week 2 and in week 3, respectively. From week 3 after the start of the drug until week 6 the patient will apply 1.8 mg/day liraglutide. In case of intolerance (e.g. occurrence of refractory nausea) at a higher dose (e.g. 1.8 mg daily, the highest dose in this trial) liraglutide can be reduced to the previous level.
  • Placebo Pen Injector — DRUG
    Matching placebo pens used to administer normal saline in the same fashion as for liraglutide

Study Details

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 randomized to liraglutide or placebo in a prospective cross over study.

Key Dates

Start date
Mar 22, 2022
Status verified
Oct 2023
Primary completion
Oct 16, 2023
Completion
Oct 16, 2023

Study Design

Enrollment
8 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Liraglutide then Placebo
    Participants will be randomly assigned to 6-week Liraglutide treatment. Then after a 5-day washout, treatment will continue with 6 weeks of placebo.
  • Experimental: Placebo then Liraglutide
    Participants will be randomly assigned to 6-week placebo treatment. Then after a 5-day washout, treatment will continue with 6 weeks of Liraglutide.

Primary Outcome Measure

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 . [ Time Frame: Baseline, Week 4 (treatment period 1) and week 10 (treatment period 2) ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of North CarolinaChapel HillNorth Carolina27599-

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By research site
University of North Carolina· Chapel Hill, NC

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