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    Summary
    EudraCT Number:2020-002313-18
    Sponsor's Protocol Code Number:PAMORA-AP_2020
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-11-27
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2020-002313-18
    A.3Full title of the trial
    The effects of opioid receptor antagonism on acute pancreatitis: An investigator initiated, randomized, placebo-controlled, double-blind clinical trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effects of opioid receptor antagonism on acute pancreatitis
    Effekten af opioid antagonisme på akut pankreatitis
    A.4.1Sponsor's protocol code numberPAMORA-AP_2020
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMech-Sense, Aalborg University Hospital
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportThe Novo Nordisk Foundation
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMech-Sense, Aalborg University Hospital
    B.5.2Functional name of contact pointCecilie Siggaard Knoph
    B.5.3 Address:
    B.5.3.1Street AddressMedicinerhuset, Mølleparkvej 4
    B.5.3.2Town/ cityAalborg
    B.5.3.3Post code9000
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4597663520
    B.5.6E-mailc.siggaard@rn.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Relistor
    D.2.1.1.2Name of the Marketing Authorisation holderPharmaSwiss
    D.2.1.2Country which granted the Marketing AuthorisationCzechia
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRelistor
    D.3.4Pharmaceutical form Injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInfusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute pancreatitis
    E.1.1.1Medical condition in easily understood language
    Acute inflammation of the pancreas
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10033647
    E.1.2Term Pancreatitis acute
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    In patients admitted with acute pancreatitis, 5 days treatment with intravenous methylnaltrexone will significantly reduce the disease severity compared to placebo.

    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal 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
    E.4Principal 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
    E.5 End points
    E.5.1Primary 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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1a. Baseline and 48 hours after randomization
    E.5.2Secondary 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
    E.5.2.1Timepoint(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
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 54
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state90
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-04-20
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