Effects of Peripherally Acting µ-opioid Receptor Antagonists on Acute Pancreatitis

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will investigate the effect of peripheral acting opioid antagonist (PAMORA) on the disease course of patients with acute inflammation of the pancreas (acute pancreatitis). The study will be conducted by treating hospitalized patients with acute pancreatitis with a PAMORA (methylnaltrexone).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asbjørn Mohr Drewes
• Collaborators: Hvidovre University Hospital; Odense University Hospital; University Hospital Bispebjerg and Frederiksberg
• Treatments: Methylnaltrexone

Criteria

Inclusion Criteria:

• Signed informed consent before any study specific procedures

• Able to read and understand Danish

• Male or female age between 18 and 80 years

• The researcher believes that the participant understands what the study entails, is capable of following instructions, can attend when needed, and is expected to complete the study

• The investigator will ensure that fertile female participants have a negative pregnancy test before treatment initiation and use contraception during the study period. The following methods of contraception, if properly used, are generally considered reliable: oral contraceptives, patch contraceptives, injection contraceptives, vaginal contraceptive ring, intrauterine device, surgical sterilization (bilateral tubal ligation), vasectomized partner, double barrier (condom and pessary), or sexual abstinence. Methods of contraception will be documented in the source documents

• At least two of the following criteria need to be fulfilled to establish a diagnosis of AP (according to the revised Atlanta criteria (16)): i) abdominal pain consistent with AP (acute onset of a persistent, severe, epigastric pain often radiating to the back); ii) serum amylase activity at least three times greater than the upper limit of normal; and iii) characteristic findings of AP on diagnostic imaging

• Onset of pain symptoms of AP < 48 hours prior to randomization

• Predicted moderate or severe AP based on 2 or more systemic inflammatory response syndrome criteria upon admission

• Both patients with AP will be included

Exclusion Criteria:

• Definitive chronic pancreatitis according to the M-ANNHEIM criteria

• Known allergy towards study medication

• Known or suspected major stenosis or perforation of the intestines

• Known or suspected abdominal cancer (incl. intestine, pancreas and the biliary tree)

• Pre-existing renal insufficiency (defined as habitual estimated glomerular filtration rate below 45)

• Severe pre-existing comorbidities (assessed by investigator upon inclusion)

• Non-pancreatic infections or sepsis caused by non-pancreatic disease

• Child-Pugh class B or C liver cirrhosis