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Effects of a Peripherally Acting µ-opioid Receptor Antagonist on Recurrent Acute Pancreatitis

NCT04966559 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2024-03-21

No results posted yet for this study

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.

Conditions

  • Pancreatitis, Acute

Interventions

DRUG

Placebo treatment

Active drug/placebo is handed out equivalent of 1 tablet of 0,2 mg Naldemedine or placebo daily for 365 days.

DRUG

Naldemedine 0.2 MG Oral Tablet

Active drug/placebo is handed out equivalent of 1 tablet of 0,2 mg Naldemedine or placebo daily for 365 days.

Sponsors & Collaborators

  • Odense University Hospital

    collaborator OTHER

  • Hvidovre University Hospital

    collaborator OTHER

  • University Hospital Bispebjerg and Frederiksberg

    collaborator OTHER

  • Karolinska University Hospital

    collaborator OTHER

  • Asbjørn Mohr Drewes

    lead OTHER

Principal Investigators

  • Asbjørn M. Drewes, Professor · Aalborg University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-12
Primary Completion
2024-03-30
Completion
2024-06-01

Countries

  • Denmark
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04966559 on ClinicalTrials.gov