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Studies

Interventional Active not recruiting Phase 2/Phase 3

NCT04966559 on ClinicalTrials.gov

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

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

  • Sponsor: Asbjørn Mohr Drewes
  • Collaborators: Odense University Hospital, Hvidovre University Hospital, University Hospital Bispebjerg and Frederiksberg, Karolinska University Hospital
  • Enrollment: 74 (Actual)
  • Study start: 2022-01-12 (Actual)
  • Primary completion: 2024-03-30 (Estimated)
  • Study completion: 2024-06-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Prevention

Brief 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

Intervention / Treatment

  • Drug: Placebo treatment
  • Drug: Naldemedine 0.2 MG Oral Tablet

Primary Outcome Measures

  • Number of AP attacks verified by the Atlanta Criteria (Observation period starts from day of randomization and ends after a minimum of 6 months and a maximum of 12 months)
    The primary outcome is defined as time to (recurrent) AP attack(s) verified by the Atlanta Criteria between the naldemedine group and the placebo group. The Atlanta Criteria is the current gold standard for the diagnosis of AP attack, and it requires a minimum of two out three of the following features: (i) Abdominal pain typical for acute pancreatitis featuring acute onset of a severe and persistent epigastric pain radiating to the back (ii) Serum amylase levels \> three times greater than the normal upper limit (iii) Findings of pancreatic inflammation in contrast-enhanced computed tomography, magnetic resonance imaging or transabdominal ultrasonography.

Countries

Denmark, Sweden

Locations and Investigators

  • Mech-Sense, Department of Medical Gastroenterology, Aalborg University Hospital, Aalborg, Denmark
  • Digestive Disease Center K, Bispebjerg University Hospital, Bispebjerg, Denmark
  • Gastrounit, Hvidovre University Hospital, Hvidovre, Denmark
  • Odense Pancreas Center, Svendborg, Denmark
  • Karolinska University Hospital, Stockholm, Sweden

Study Officials