The effects of opioid receptor antagonism on acute pancreatitis

Phase 1

• Conditions: 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: EUCTR2020-002313-18-DK
• Lead Sponsor: Mech-Sense, Aalborg University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-27
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 90

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.
•Within the current hospital admission and prior to inclusion, the patient must fulfill at least two of the following criteria 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 the fulfillment of 2 or more SIRS criteria within the last 24 hours prior to 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 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

•Definitive chronic pancreatitis according to the M-ANNHEIM criteria
•Known allergy towards study medication
•Known or suspected major obstruction or perforation of the intestines
•Toxic megacolon
•Known or suspected abdominal cancer (incl. intestine, pancreas and the biliary tree)
•Pre-existing renal insufficiency (defined as habitual eGFR below 45)
•End-stage renal impairment requiring dialysis prior to inclusion
•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

Study & Design

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