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

• Status: Not yet recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

Criteria

Inclusion Criteria:

• Signed informed consent before any study specific procedures

• Able to read and understand Danish or Swedish (depending on site)

• Male or female age between 18 and 74 years

• At least one attack of non-biliary AP (as defined by the revised Atlanta criteria) within the last 12 months and at least two attacks within 5 years

• Clinically stable at time of inclusion

• 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

Exclusion 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 eGFR below 45)

• Female participants that are lactating

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

• Attack of AP requiring admission within two weeks prior to inclusion

• Gallstone etiology of RAP (MRCP or endoscopic ultrasound excluding biliary etiology of AP must be available prior to enrolment as part of the protocol)

• Treatment with potent CYP3A4-inhibitors (ketoconazol, itraconzol, ritonavir) or P-gp inhibitors (e.g. cyclosporine).