Evidence map›Paper›PMID 41553774›Full record

Trial reportUnited European gastroenterology journal2026

Naldemedine for the Prevention of Recurrent Acute Pancreatitis: A Randomised, Double-Blind, Placebo-Controlled Trial.

Mathias E Cook, Cecilie S Knoph, Line Davidsen, Jens B Frøkjær, Niels H Bruun, Srdan Novovic, Amer Hadi, Maiken Thyregod Jørgensen, Michael B Mortensen, Ove Schaffalitzky and 4 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in United European gastroenterology journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04966559 (Effects of a Peripherally Acting µ-opioid Receptor Antagonist on Recurrent Acute Pancreatitis An Investigator-initiated, Randomized, Placebo-controlled, Double-blind Clinical Trial), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04966559 phase2 / phase3unknown statusnot on this map

Effects of a Peripherally Acting µ-opioid Receptor Antagonist on Recurrent Acute Pancreatitis An Investigator-initiated, Randomized, Placebo-controlled, Double-blind Clinical Trial

TypeinterventionalSponsorAsbjørn Mohr DrewesRan2022 to 2024Enrolled74ConditionsPancreatitis, AcuteArmsPlacebo treatment, Naldemedine 0.2 MG Oral Tablet
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. UEG Journal-In Times of Turmoil, Science Matters.United European gastroenterology journal · 2026
    Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Mathias E CookCentre for Pancreatic Diseases and Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark.ORCID https://orcid.org/0000-0002-4157-1091
Cecilie S KnophCentre for Pancreatic Diseases and Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark.ORCID https://orcid.org/0000-0002-8373-1487
Line DavidsenCentre for Pancreatic Diseases and Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark.ORCID https://orcid.org/0000-0002-1120-8144
Jens B FrøkjærDepartment of Clinical Medicine, Aalborg University, Aalborg, Denmark.ORCID https://orcid.org/0000-0001-8722-0070
Niels H BruunResearch Data and Biostatistics, Aalborg University Hospital, Aalborg, Denmark.ORCID https://orcid.org/0000-0002-2644-4115
Srdan NovovicGastrounit, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.ORCID https://orcid.org/0000-0001-6246-874X
Amer HadiGastrounit, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.
Maiken Thyregod JørgensenDepartment of Internal Medicine, SLB Vejle Hospital, Vejle, Denmark.ORCID https://orcid.org/0009-0004-1874-0012
Michael B MortensenOdense Pancreas Centre (OPAC), HPB Section, Department of Surgery, Odense University Hospital, Odense, Denmark.ORCID https://orcid.org/0000-0002-7270-5005
Ove SchaffalitzkyOdense Pancreas Centre (OPAC), HPB Section, Department of Surgery, Odense University Hospital, Odense, Denmark.ORCID https://orcid.org/0000-0003-1969-2329
Liv B J NielsenDigestive Disease Centre K, Copenhagen University Hospital Centre, Copenhagen, Denmark.
Mark Berner-HansenDigestive Disease Centre K, Copenhagen University Hospital Centre, Copenhagen, Denmark.ORCID https://orcid.org/0000-0003-1305-3382
Asbjørn M DrewesCentre for Pancreatic Diseases and Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark.ORCID https://orcid.org/0000-0001-7465-964X
Søren S OlesenCentre for Pancreatic Diseases and Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark.ORCID https://orcid.org/0000-0003-3916-3168

Funding

Health Research Foundation of North Denmark Region 2022-0024Novo Nordisk Fonden NNF19OC0057331Shionogi
6 · The paper itself

Abstract

BACKGROUND AND

aimsNo medications are currently approved for the prevention of recurrent acute pancreatitis. This trial evaluated whether naldemedine, a peripherally acting μ-opioid receptor antagonist, reduces the risk of acute pancreatitis in patients with recurrent acute pancreatitis.

methodsThis was a multicentre, double-blinded, placebo-controlled randomised trial conducted at four Danish pancreatitis referral centres. Participants aged 18-75 years with recurrent acute pancreatitis, both with and without a diagnosis of chronic pancreatitis, were randomised to receive naldemedine 0.2 mg or a matching placebo daily for up to 12 months. The primary outcome was acute pancreatitis recurrence, defined by the revised Atlanta Criteria. Secondary outcomes included pain flares, gastrointestinal symptoms, and quality of life. At the end of follow-up, the participant's global impression of change, safety and tolerability outcomes, new-onset diabetes and pancreatic exocrine insufficiency were assessed.

results74 participants (mean age: 46 years; 41% female) were randomised to naldemedine (n = 36) or placebo (n = 38). During a median follow-up time of 365 days (IQR, 352-370), participants in the naldemedine group had a numerically lower risk of acute pancreatitis compared to placebo (HR 0.54; 95% CI, 0.29-1.01; p = 0.05). No differences were observed between the groups for secondary efficacy, safety, and tolerability outcomes. Participants treated with naldemedine for at least 1 year had a lower risk of acute pancreatitis (HR 0.49; 95% CI, 0.24-0.97; p = 0.04).

conclusionsTreatment with naldemedine was safe and well-tolerated and may reduce the risk of recurrent acute pancreatitis. A larger confirmatory trial is needed to verify these findings.

trial registrationClinicalTrials.gov Identifier: PAMORA-RAP: NCT04966559.

Indexed as

NaltrexoneNarcotic AntagonistsPancreatitisSecondary PreventionAcute DiseaseAdolescentAdultAgedDenmarkDouble-Blind MethodFemaleHumansMaleMiddle AgedQuality of LifeReceptors, Opioid, munaldemedineNaltrexoneNarcotic AntagonistsReceptors, Opioid, munaldemedineopioid receptorsPAMORARCTrecurrent acute pancreatitis

Identifiers

PMID41553774
PMCPMC12815247

What Socratic holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.