drugset / Trial / NCT04966559
Effects of a Peripherally Acting µ-opioid Receptor Antagonist on Recurrent Acute Pancreatitis
Phase 2/3
Unknown
74 enrolled
Asbjørn Mohr Drewes
Hvidovre University Hospital · collabKarolinska University Hospital · collabOdense University Hospital · collabUniversity Hospital Bispebjerg and Frederiksberg · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This study will investigate the effect of a peripheral acting opioid antagonist (PAMORA) on the disease course of patients with recurrent acute inflammation of the pancreas (acute pancreatitis). The study will be conducted by treating outpatients suffering from recurrent acute pancreatitis with a PAMORA (naldemedine) for 12 months.
Timeline
- Start
- 2022-01-12
- Primary completion
- 2024-03-30
- Completion
- 2024-06-01
Publications
- Cook ME, Knoph CS, Davidsen L, Frokjaer JB, Bruun NH, Novovic S, Hadi A, Jorgensen MT, Mortensen MB, Schaffalitzky O, Nielsen LBJ, Berner-Hansen M, Drewes AM, Olesen SS. Naldemedine for the Prevention of Recurrent Acute Pancreatitis: A Randomised, Double-Blind, Placebo-Controlled Trial. United European Gastroenterol J. 2026 Feb;14(1):e70178. doi: 10.1002/ueg2.70178.
- Cook ME, Knoph CS, Fjelsted CA, Frokjaer JB, Bilgrau AE, Novovic S, Jorgensen MT, Mortensen MB, Nielsen LBJ, Hadi A, Berner-Hansen M, Rutkowski W, Vujasinovic M, Lohr M, Drewes AM, Olesen SS. Effects of a peripherally acting micro-opioid receptor antagonist for the prevention of recurrent acute pancreatitis: study protocol for an investigator-initiated, randomized, placebo-controlled, double-blind clinical trial (PAMORA-RAP trial). Trials. 2023 May 1;24(1):301. doi: 10.1186/s13063-023-07287-z.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Naldemedine | Other / unclassified | 0.2 mg | Oral |