Effects of Peripherally Acting µ-opioid Receptor Antagonists on Acute Pancreatitis - An Investigator-initiated, Randomized, Placebo-controlled, Double-blind Clinical Trial

PAMORA_AP, PAMORA-1

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).

2021-05-14

2023-04-09

2023-04-20

Completed

Early phase I

105

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 * Predicted moderate or severe AP based on 2 or more systemic inflammatory response syndrome criteria upon admission 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) * Severe non-pancreaticobiliary infections or sepsis caused by non-pancreaticobiliary disease * Child-Pugh class B or C liver cirrhosis * Females that are currently lactating

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 105, 'type': 'ACTUAL'}}

2023-04-21