Acute pancreatitis MedDRA version: 20.0 Level: PT Classification code 10033647 Term: Pancreatitis acute System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: Relistor
Product Name: Relistor
Pharmaceutical Form: Injection/infusion
Pharmaceutical form of the placebo: Infusion
Route of administration of the placebo: Intravenous use
Sponsors
Mech-Sense, Aalborg University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In patients admitted with acute pancreatitis, 5 days treatment with intravenous methylnaltrexone will significantly reduce the disease severity compared to placebo. ;Secondary Objective: Not applicable ;Primary end point(s): Primary endpoint 1a. Difference in Pancreatitis activity scoring system (PASS) score between the methylnaltrexone group and the placebo group 48 hours after randomization. ;Timepoint(s) of evaluation of this end point: 1a. Baseline and 48 hours after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints acute pancreatitis 2a. Difference in PASS scores between subgroups 3a. Difference in assessments of pro- and anti-inflammatory markers between subgroups 4a. Difference in intestinal permeability between subgroups measured from 24 to 48 hours after randomization using the oral polyethylene glycol 400/4000 test 5a. Difference in intestinal motility assessed by means of gut/colon transit using a CT based radiopaque maker method between subgroups 6a. Difference in pancreatic edema, fluid collections and necrosis assessed and quantified with contrast-enhanced CT 7a. Difference between subgroups in the following clinical outcome parameters: pain intensity and gut function (assessed by questionnaires), quantification of nutritional support and analgesics, disease severity, invasive treatments, intensive care and hospital stay, as well as mortality during total hospitalization 8a. Difference in health resource utilization during hospitalization between subgroups;Timepoint(s) of evaluation of this end point: 2a. Daily from randomization to end of study day 5 3a. Daily from randomization to end of study day 5 4a. 24 to 28 hours after randomization 5a. End of study day 5 after randomization 6a. End of study day 5 after randomization 7a. End of study day 5 after randomization 8a. End of study day 5 after randomization | — |
Countries
Denmark
Contacts
Public ContactCecilie Siggaard Knoph
Mech-Sense, Aalborg University Hospital
Outcome results
None listed