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    Summary
    EudraCT Number:2015-003987-35
    Sponsor's Protocol Code Number:Metamizole001
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-10-07
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2015-003987-35
    A.3Full title of the trial
    Metamizole versus NSAID at home after ambulatory surgery: a double-blind randomized controlled trial
    Metamizole versus NSAID voor pijnstilling thuis na ambulante chirurgie: een dubbelblind gerandomiseerd onderzoek met controlegroep
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Metamizole versus NSAID, two painkillers for painrelief at home after day surgery: a double-blind randomized controlled trial
    A.4.1Sponsor's protocol code numberMetamizole001
    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 SponsorJESSA Hospital
    B.1.3.4CountryBelgium
    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 supportJESSA Hospital
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJESSA Hospital
    B.5.2Functional name of contact pointStessel Björn
    B.5.3 Address:
    B.5.3.1Street AddressStadsomvaart 11
    B.5.3.2Town/ cityHasselt
    B.5.3.3Post code3500
    B.5.3.4CountryBelgium
    B.5.4Telephone number0032479292433
    B.5.6E-mailbjorn.stessel@jessazh.be
    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 Novalgine
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Belgium
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameMetamizole
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Brufen
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz nv
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameIbuprofen
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pain after ambulatory surgery
    E.1.1.1Medical condition in easily understood language
    Pain after day surgery
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study was twofold:
    1) to assess and compare the analgesic efficacy of a combination of metamizol and paracetamol with our current pain protocol (a combination of paracetamol and ibuprofen) in the treatment of acute postoperative pain at home after painful day-case surgery. We hypothesized that ambulatory patients postoperatively treated with metamizol/paracetamol would achieve equal or even better pain relief compared to patients treated with ibuprofen/paracetamol.
    2) To assess and compare recovery profile of two the study groups

    Het primaire doel van deze studie is tweeledig:
    1. Het bestuderen en vergelijken van de analgetische kracht van een combinatie van paracetamol en dipyrone in een groep van patiënten die pijnlijke ambulante chirurgie ondergaan met het standaard pijnprotocol (paracetamol/ibuprofen). Onze hypothese is dat de combinatie van paracetamol met dipyrone minstens een even grote pijnreductie geeft vergeleken met het huidige standaard pijn protocol.
    2. Het bestuderen en vergelijken van het herstelprofiel van de twee behandelgroepen.
    E.2.2Secondary objectives of the trial
    - to assess adverse effects of study medication
    - to assess compliance with study medication
    - to assess use of rescue medication
    - to assess satisfaction with study medication
    - to assess predictors of postoperative pain and poor recovery
    Secundaire onderzoeksdoelen zijn het nagaan van eventuele nadelige effecten van studiemedicatie, het gebruik van rescue-medicatie (dipidolor iv in recovery en tramadol oraal thuis), het bestuderen van de patiënttevredenheid, de compliantie met studiemedicatie en predictoren van postoperatieve pijn en recovery
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients aged between 18 and 70 years
    - ASA classification 1,2 or 3
    - one of the following ambulatory surgical procedures:
    - anal surgery (anal fissura or haemmorrhoids)
    - arthroscopy knee
    - arthroscopy shoulder with interscalenus block
    - inguinal hernia repair
    - Patiënten in de leeftijdscategorie ≥18 jaar en ≤70jaar
    - ASA classificatie 1,2 of 3
    - 1 van de volgende ingrepen: Anale chirurgie (Anale fissuur of haemmorhoïden), arthroscopie knie, arthroscopie schouder met interscalenusblok en liesbreukherstel
    E.4Principal exclusion criteria
    not meeting inclusion criteria, cognitive impairment or no understanding of the dutch language, preoperative pharmacologic pain treatment with opioids, chronic pain (fibromyalgia, CRPS, etc), allergy to or a contraindication for taking the study medication (e.g. paracetamol, metamizole, ibuprofen or another NSAID), porphyria, pregnancy, lactation, history of severe renal, hepatic, pulmonary, or cardiac failure, current symptoms or history of gastrointestinal bleeding, ileus, chronic obstipation, history of substance abuse, or use of medication with a suppressive effect on the central nervous system, hypotension, hematological disaese, use of anti-rheumatic drugs, rhinosinusitis or nasal polyposis, Glucose-6-phosphate dehydrogenase deficiency, fever or other signs of infection
    - Leeftijd <18 jaar en >70 jaar
    - Onmogelijke toepassing van de NRS voor de meting van de pijnintensiteit. Vb: visuele dysfunctie, dementie, geen beheersing Nederlandse taal
    - Preoperatieve therapie met opioïden
    - Chronische pijn patiënten (fibromyalgie, CRPS, enz)
    - Overgevoeligheid voor metamizole, alcohol, paracetamol of ibuprofen (en andere NSAIDs)
    - Porphyrie
    - Congenitaal tekort aan glucose-6-fosfaat dehydrogenase
    - Zwangerschap en borstvoeding
    - Ernstige nier- en leverfunctiestoornissen
    - Astma of Ernstige COPD, emfyseem
    - Rhinosinusitis of neuspoliepen
    - Chronische obstipatie
    - Gebruik van anti-rheumatische middelen
    - Hematologische ziekte
    - Hypotensie
    - Ulcus pepticum, maagdarmbloedingen: actief of in de anamnese
    - Gastro-intestinale bloeding of perforatie als gevolg van gebruik van cyclooxygenase-inhibitoren in de anamnese
    - Ernstig hartfalen
    - Opioidabusus, alcoholabusus of abusus van andere centraal depressieve stoffen de in de anamnese
    - Koorts of andere tekens van acute infectie
    E.5 End points
    E.5.1Primary end point(s)
    • Postoperative pain intensity measured by Numerical Rating Score (NRS): is there a difference in postoperative pain intensitiy between the two study groups? A small difference of more than 1 point (on NRS) is deliberately considered clinically relevant, since we make use of a non-inferiority design.
    • Postoperative quality of recovery, measured by three tools:
    o Global Surgical Recovery (GSR)
    o EQ-5D (an instrument to measure quality of life)
    o Functional Recovery Index (FRI)
    -> Is there a difference in quality of recovery between the two study groups?
    • Postoperatieve pijnintensiteit gemeten door Numerical Rating Score (NRS).
    Vraagstelling: Is er een verschil in postoperatieve pijnintensiteit in de verschillende behandelgroepen? Een verschil van meer dan 1 punt op de NRS wordt als klinisch relevant beschouwd. Dit verschil wordt bewust zo klein gehouden omdat het een non-inferiority trial betreft.
    • Postoperatief herstel gemeten door de Global Surgical Recovery (GSR), de verschil-score van de EQ-5D en de FRI (Functional Recovery Index)
    Vraagstelling: Is er een verschil in herstel in de verschillende behandelgroepen, gemeten met de 3 verschillende meetinstrumenten?
    E.5.1.1Timepoint(s) of evaluation of this end point
    Pain intensity will be assessed at movement and at rest by NRS pre-operatively (baseline) and postoperatively in the postanesthetic
    care unit (PACU) and in the surgical holding area before discharge (day 0). After discharge postoperative pain intensity at rest and at movement will be assessed by NRS one time a day using a diary for up to 96 hours after surgery (day 1,2,3,4), and also at one week (day 7), two weeks (day 14) and one month (day 28) after surgery.
    For quality of recovery, a baseline measurement of EQ-5D and FRI will be done preoperatively. Quality of recovery will be assessed by GSR, EQ-5D and FRI one time a day for up to 96 hours after surgery (day 1,2,3,4) and also at one week (day 7) two weeks (day 14) and one month (day 28) after surgery.
    Pijnintensiteit:
    NRS wordt voor de ingreep (basislijn), op de recovery na de ingreep en voor ontslag naar huis gemeten.
    De patiënten wordt een dagboek meegegeven, waarin 1 keer per dag de NRS in rust en de NRS bij beweging ingevuld wordt (dag 1 t.e.m. 4 en dag 7).
    Tevens wordt de NRS in rust en beweging op dag 14 en 28 gemeten.
    Kwaliteit van herstel:
    Voor de ingreep (basislijn) wordt de pre-operatieve EQ-5D en PQRS gemeten
    Op postoperatieve dagen 4, 7, 14, 28 wordt de de GSR, de post-operatieve EQ-5D en de PQRS
    gescoord.

    E.5.2Secondary end point(s)
    - to assess adverse effects of study medication: PONV, micturition problems, pyrosis, constipation, abdominal complaints, signs of agranulocytosis or thrombocytopenia, etc.
    - to assess compliance with study medication by checking whether patients used the study medication as prescribed and the use of other pain medication
    - to assess use of rescue medication: amount of iv piritramide applied at the PACU and amount of tramadol taken at home
    - to assess patient satisfaction with study medication by an 11-point numeric scale
    - to assess predictors of postoperative pain and poor recovery
    • Neveneffecten van de gebruikte analgetica: pyrosis, tekens van agranulocytosis of thrombocytopenie, enz
    • Patiënttevredenheid met studiemedicatie
    • Gebruik van rescue-medicatie (dipidolor in recovery en tramadol thuis)
    • Compliantie met studiemedicatie thuis
    E.5.2.1Timepoint(s) of evaluation of this end point
    - adverse effects of study medication: postoperative day 0,1,2,3,4,7,14,28
    - compliance with study medication: postoperative day 0,1,2,3,4
    - use of rescue medication: postoperative day 0,1,2,3,4
    - patient satisfaction with study medication: postoperative day 7
    - to assess predictors of postoperative pain: postoperative day 0,1,2,3,4
    - to assess predictors of poor recovery: postoperative day 4,7,14,28
    • Neveneffecten van de gebruikte analgetica: dag 0,1,2,3,4,7,14,28 postoperatief
    • Patiënttevredenheid met studiemedicatie: dag 7 postoperatief
    • Gebruik van rescue-medicatie: dag 0,1,2,3,4 postoperatief
    • Compliantie met studiemedicatie thuis: dag 1,2,3,4 postoperatief
    • Predictoren van postoperatieve pijn: dag 1,2,3,4 postoperatief
    • Predictoren van slecht herstel: dag 4,7,14,28 postoperatief
    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 Yes
    E.6.5Efficacy Yes
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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) Yes
    E.8.2.2Placebo No
    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 No
    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 years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 170
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state200
    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 Decision2015-11-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-21
    P. End of Trial
    P.End of Trial StatusOngoing
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