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    Summary
    EudraCT Number:2020-004237-21
    Sponsor's Protocol Code Number:Metamizole003
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-11-03
    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 number2020-004237-21
    A.3Full title of the trial
    Evaluation of the added value of Metamizole to standard postoperative treatment after ambulant shoulder surgery: a double-blind, randomized controlled trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of Metamizole to standard postoperative treatment after ambulant shoulder surgery
    A.3.2Name or abbreviated title of the trial where available
    Metamizole003
    A.4.1Sponsor's protocol code numberMetamizole003
    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 AddressSalvatorstraat 20
    B.5.3.2Town/ cityHasselt
    B.5.3.3Post code3500
    B.5.3.4CountryBelgium
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMETAMIZOLE
    D.3.9.1CAS number 50567-35-6
    D.3.9.2Current sponsor codeSanofi
    D.3.9.3Other descriptive nameNovalgin
    D.3.9.4EV Substance CodeSUB03187MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Optimalisation of postoperative treatment after ambulant shoulder arthroscopy
    E.1.1.1Medical condition in easily understood language
    Evaluation of pain medication after shoulder 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
    This study aims to investigate if the combination of metamizole and paracetamol is superior in reducing post-operative pain on day 1 after ambulatory shoulder surgery where the use of NSAIDs is prohibited compared to paracetamol treatment.
    E.2.2Secondary objectives of the trial
    - Quality of Recovery at baseline and days 7, 14, 28, and 3 months postoperatively.
    - Postoperative pain intensity at rest and movement measured by NRS at baseline, at discharge, and day 1, 2, 3, 4, 7, 14, 28, and 3 months postoperatively.
    - Total pain relief was evaluated at day 1, 2, 3, 4, 7, 14, 28, and 3 months postoperatively
    - A simple shoulder test (SST) was measured at baseline and days 7, 14, 28, and 3 months postoperatively.
    - Adherence to study medication on days 1, 2, 3, and 4 postoperatively.
    - Adverse effects of the study medication (i.e. pyrosis, signs of agranulocytosis or thrombocytopenia)
    - The total amount of intravenous piritramide received in the PACU
    - The use of rescue medication (Tramadol) at home on day 1, 2, 3 and 4 postoperatively (yes/no)
    - Satisfaction with study medication, surgery, and hospital care and telephone follow-up measured at day 7 and 3 months postoperative by NRS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients aged between 18 and 75 years
    - ASA classification 1, 2 or 3
    - Bodyweight > 50 kg
    - Undergoing ambulatory arthroscopic shoulder surgery and with a contraindication to NSAID (SAD ± ACJ excision or decompression, decompression + biceps tenodesis, SLAP repair, Bankart repair, rotator cuff repair)
    E.4Principal exclusion criteria
    - Not meeting inclusion criteria
    - Cognitive impairment or no understanding of the Dutch language
    - Preoperative pharmacological pain treatment and/or a history of chronic pain excluding shoulder pain
    - Allergy to or contraindication for taking the study medication (e.g. paracetamol or metamizole)
    - Porphyria
    - Pregnancy or lactation
    - A history of severe renal, hepatic, pulmonary or cardiac failure
    - A history of substance abuse, or use of medication with a suppressive effect on the central nervous system
    - Hypotension
    - Hematological disease
    - Use of anti-rheumatic drugs
    - Rhinosinusitis or nasal polyposis
    - Glucose-6-phosphate dehydrogenase deficiency
    - Fever or other signs of infection
    - Refusal of an interscalene block
    E.5 End points
    E.5.1Primary end point(s)
    Postoperative pain intensity at movement measured by an 11-point Numeric Rating Scale (NRS), where 0: no pain and 10: worst imaginary pain, on postoperative day 1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Postoperative day 1
    E.5.2Secondary end point(s)
    - Quality of Recovery measured by the 1-item Global Surgical Recovery (GSR) index and the EuroQol (EQ5D) questionnaire at baseline and days 7, 14, 28, and 3 months postoperatively.
    - Postoperative pain intensity at rest and movement measured by NRS at baseline, at discharge, and day 1, 2, 3, 4, 7, 14, 28, and 3 months postoperatively.
    - Total pain relief was evaluated at day 1, 2, 3, 4, 7, 14, 28, and 3 months postoperatively, with 0 indicating none, 1 indicating slight, 2 indicating moderate, 3 indicating substantial and 4 indicating complete pain relief.
    - A simple shoulder test (SST) was measured at baseline and days 7, 14, 28, and 3 months postoperatively.
    - Adherence to study medication on days 1, 2, 3, and 4 postoperatively.
    - Adverse effects of the study medication (i.e. pyrosis, signs of agranulocytosis or thrombocytopenia)
    - The total amount of intravenous piritramide received in the PACU
    - The use of rescue medication (Tramadol) at home on day 1, 2, 3 and 4 postoperatively (yes/no)
    - Satisfaction with study medication, surgery, and hospital care and telephone follow-up measured at day 7 and 3 months postoperative by NRS.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Quality of Recovery at baseline and days 7, 14, 28, and 3 months postoperatively.
    - Postoperative pain intensity at rest and movement and total pain relief at baseline, at discharge, and day 1, 2, 3, 4, 7, 14, 28, and 3 months postoperatively.
    - A simple shoulder test (SST) was measured at baseline and days 7, 14, 28, and 3 months postoperatively.
    - Adherence to study medication on days 1, 2, 3, and 4 postoperatively.
    - Adverse effects of the study medication
    - The total amount of intravenous piritramide received in the PACU
    - The use of rescue medication (Tramadol) at home on day 1, 2, 3 and 4 postoperatively
    - Satisfaction with study medication, surgery, and hospital care and telephone follow-up measured at day 7 and 3 months postoperative by NRS.
    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) 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 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 months
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state110
    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 Decision2020-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-12-22
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