The effects of peripheral opioid receptor antagonism on recurrent acute pancreatitis

Phase 1

• Conditions: Recurrent acute pancreatitis; MedDRA version: 20.0Level: PTClassification code 10033647Term: Pancreatitis acuteSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2021-000069-34-DK
• Lead Sponsor: Mech-Sense, Aalborg University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-05
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

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
• 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
• Clinically stable at time of inclusion
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 91
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 29

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 four 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 such (e.g. cyclosporine).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: In outpatients with recurrent acute pancreatitis it will be investigated whether 12 months treatment with oral naldemedine will significantly reduce the number of pancreatitis attacks as compared to placebo.;Secondary Objective: Not applicable;Primary end point(s): Individual difference in number of AP attacks verified by the Atlanta criteria between the naldemedine group and the placebo group during the 12-month treatment period;Timepoint(s) of evaluation of this end point: Monthly telephone interviews (Month 1-12) and end of study visit after 12 months