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    Summary
    EudraCT Number:2013-004709-17
    Sponsor's Protocol Code Number:MP_SM01_2013
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-02-10
    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 number2013-004709-17
    A.3Full title of the trial
    Effect of High-dose Naloxone Infusion on Pain and Hyperalgesia in Inguinal Post-herniotomy Patients – A Randomized, Placebo-controlled, Double-blind Study
    Effekt af Høj-dosis Naloxon Infusion på smerte og hyperalgesi hos patienter opereret for ingvinalhernie - en randomiseret, placebo-kontrolleret, dobbeltblindet studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of naloxon, a drug that removes the effect of morfin), on pain hypersensitivity after a inguinal herniotomy operation.
    Effekten af sen indgift at af naloxon, et stof der ophæver morfins virkning, på smerteover-følsomhed efter lyskebrok operation.
    A.4.1Sponsor's protocol code numberMP_SM01_2013
    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 SponsorRigshospitalet
    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 supportRigshospitalet
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRigshospitalet
    B.5.2Functional name of contact pointKaren Lisa Hilsted
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number004535459502
    B.5.6E-mailKaren.lisa.hilsted@regionh.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 Naloxone
    D.2.1.1.2Name of the Marketing Authorisation holderB. Braun Medical
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNaloxone
    D.3.9.3Other descriptive nameNALOXONE HYDROCHLORIDE DIHYDRATE
    D.3.9.4EV Substance CodeSUB12168MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous bolus use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    First degree burn injury in healthy volunteers who 6-8 weeks prior have had done a Inguinal herniotomy .
    Første grads forbrænding hos raske frivillige forsøgspersoner, som 6-8 forinden har fået foretaget en ingvinal herniotomi.
    E.1.1.1Medical condition in easily understood language
    A light heat injury (reddening of the skin, pain with touch of the area) in healty volunteers who 6-8 weeks prior have had done a Inguinal herniotomy.
    Første grads forbrænding hos raske frivillige forsøgspersoner, som 6-8 forinden har fået foretaget foretaget en brok operation i lysken.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10049475
    E.1.2Term Chronic pain
    E.1.2System Organ Class 100000004867
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    A composite measure of pain (NRS 0-10) at rest + pain during transition from supine to standing position + pain during pressure (100 kPa) at injury site, assessed six to eight weeks after a unilateral, primary, inguinal, open herniotomy following administration of naloxone.
    En sammensat mål for smerte (NRS 0-10) i hvile + smerter under overgangen fra liggende til stående stilling + smerter under tryk (100 kPa) ved operationarret, vurderet seks til otte uger efter en ensidig, primær åben lyske herniotomy efter administration af naloxon.
    E.2.2Secondary objectives of the trial
    Secondary hyperalgesia/allodynia area at injury site and contralateral site
    Secondary hyperalgesia induced by Brief Thermal Stimulation in the thigh contralateral to the injury site
    Warmth detection thresholds (WDT) and Heat Pain Detection Thresholds (HPDT) at injury site and contralateral site Mechanical pain thresholds (MPT) at injury site and contralateral site
    Pressure pain thresholds (PPT) at injury site and contralateral site
    Reaction time assessment before and after infusion
    Hospital Anxiety and Depression Scale (HADS) before assessments are performed
    Pain Catastrophizing Scale (PCS) before assessments are performed
    Clinical Opiate Withdrawal Scale (COWS) before assessments are performe
    Sekundær hyperalgesi / allodynia omkring operationsarret og modsat dette.
    Sekundær hyperalgesi induceret af Brief Thermal Stimulation på låret modsat operationsarret
    Varmedetektions grænsen ( WDT) og varme smerter detekteringsgrænse ( HPDT ) ved operationsarret og modsat dette.
    Mekaniske smertetærsklen ( MPT ) ved oeprationsarret og kontralateralt dette.
    Tryk smertetærsklen ( PPT ) ved operationsarret og modsat dette.
    Reaktionstid vurdering før og efter infusion
    Sygehus Angst og Depression Scale ( HADS ), før vurderingerne udføres
    Smerter Catastrophizing Scale (PCS ), før vurderingerne udføres
    Klinisk Opiate Tilbagetrækning Scale (COWS ), før vurderingerne udføres
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Healthy male
    • Age  18 år og  65 years
    • Signed informed consent
    • Patients submitted to unilateral, primary inguinal, open herniotomy 6-8 weeks prior to study start.
    • Open operating procedure a.m. Lichtenstein.
    • Urin sample without traces of opioids (morphin, methadon, buprenorphine, codeine, tramadol, ketobemidone, oxycodone, hydromorphone, dextromethorphan)
    • ASA I-II
    • Body mass index (BMI): 18 < BMI < 30
    Sund mand
    • Alder  18 year and  65 år
    • Underskrevet informeret samtykke
    • Patienter sendt til ensidig, primær lyske, åben herniotomy 6-8 uger før forsøgets start.
    • Åben operationsprocedure a.m. Lichtenstein.
    • Urin prøve uden spor af opioider (morphin, methadon, buprenorphin, codein, tramadol, ketobemidon, oxycodon, hydromorphon, dextromethorphan)
    • ASA I-II
    • Body mass index (BMI): 18 <BMI <30
    E.4Principal exclusion criteria
    • Volunteers , who do not speak or understand Danish
    • Volunteers, who cannot cooperate with the investigation
    • Volunteers, who have had previous surgery in the groin region
    • Volunteers with pain at rest > 3 (NRS)
    • Activity-related pain in the surgical field > 5 (NRS)
    • Allergic reaction against morphine or other opioids (including naloxone),
    • Abuse of alcohol or drugs – according to investigator’s evaluation
    • Use of psychotropic drugs (exception of SSRI)
    • Neurologic or psychiatric disease
    • Chronic pain condition
    • Regular use of analgesic drugs
    • Skin lesions and tattoos in the assessment areas
    • Nerve lesions in the assessment sites (for instance, after trauma, disc herniation, etc.)
    • Use of prescription drugs one week before the trial
    • Use of over-the-counter drugs 48 hours before the trial
    • Frivillige, der ikke taler eller forstår dansk
    • Frivillige, der ikke kan samarbejde med undersøgelsen
    • Frivillige, der har haft tidligere operation i lysken regionen
    • Frivillige med smerter i hvile> 3 (NRS)
    • Aktivitets-relaterede smerter i det kirurgiske område> 5 (NRS)
    • Allergisk reaktion mod morfin eller andre opioider (herunder naloxon)
    • Misbrug af alkohol eller narkotika - ifølge investigators vurdering
    • Brug af psykofarmaka (undtagen SSRI)
    • Neurologisk eller psykiatriske sygdomme
    • Kroniske smerter tilstand
    • Regelmæssig brug af smertestillende medicin
    • Hud læsioner og tatoveringer i vurderingen områder
    • Nerve læsioner i de vurderingskriterier websteder (f.eks efter traumer, discusprolaps, etc.)
    • Brug af receptpligtig medicin en uge før retssagen
    • Brug af over-the-counter medicin 48 timer før retssagen
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome is areas of secondary hyperalgesia
    Primære outcome er sekundær hyperalgesi arealer
    E.5.1.1Timepoint(s) of evaluation of this end point
    Thermal thresholds are assessed at baseline and 1,2,3 hours after the burn injurys.
    Mechanical thresholds are assessed at baseline and 1,2,3,165,168,168½ hrs after the burn injurys
    Varme tærskler vurderes ved baseline og 1,2,3 timer efter brandskade.
    Mekaniske tærskler vurderes ved baseline og 1,2,3,165,168,168 ½ timer efter brandskade
    E.5.2Secondary end point(s)
    Thermal and mechanical thresholds and psychometrics
    Termiske og mekaniske tærskler og psykiske vurderinger
    E.5.2.1Timepoint(s) of evaluation of this end point
    Thermal thresholds are assessed at baseline and 1,2,3 hours after the burn injurys.
    Mechanical thresholds are assessed at baseline and 1,2,3,165,168,168½ hrs after the burn injurys
    Varme tærskler vurderes ved baseline og 1,2,3 timer efter brandskade.
    Mekaniske tærskler vurderes ved baseline og 1,2,3,165,168,168 ½ timer efter brandskade
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    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) No
    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 No
    E.8.1.6Cross over Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS - sidste besøg sidste forsøgsperson
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    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: 14
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state16
    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
    Ingen
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Department of Surgery, Herlev Hospital
    G.4.3.4Network Country Denmark
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-02-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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