Effects of a peripherally acting µ-opioid receptor antagonist on recurrent acute pancreatitis: An investigator-initiated, randomized, placebo-controlled, double-blind clinical trial

Mech-Sense, Aalborg University Hospital0 sites120 target enrollmentOctober 5, 2021

Overview

No summary available.

Registry

who.int

Start Date

October 5, 2021

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Mech-Sense, Aalborg University Hospital

•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

•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).