Effects of a Peripherally Acting µ-opioid Receptor Antagonist on Recurrent Acute Pancreatitis (NCT04966559) | Clinical Trial Compass
UnknownPhase 2/3
Effects of a Peripherally Acting µ-opioid Receptor Antagonist on Recurrent Acute Pancreatitis
Denmark, Sweden74 participantsStarted 2022-01-12
Plain-language 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.
Who can participate
Age range18 Years – 74 Years
SexALL
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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-exi…
What they're measuring
1
Number of AP attacks verified by the Atlanta Criteria
Timeframe: Observation period starts from day of randomization and ends after a minimum of 6 months and a maximum of 12 months