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    Summary
    EudraCT Number:2013-000381-11
    Sponsor's Protocol Code Number:NL42823.018.13
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-05-17
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-000381-11
    A.3Full title of the trial
    Paracetamol or NSAID's in acute musculoskeletal syndromes
    Paracetamol of NSAID's bij acute musculoskeletale syndromen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Paracetamol or NSAID’s in acute disorders of the musculoskeletal tract
    Paracetamol of NSAID’s bij acute aandoeningen van het bewegingsapparaat
    A.3.2Name or abbreviated title of the trial where available
    The PanAM Study
    De PanAM Studie
    A.4.1Sponsor's protocol code numberNL42823.018.13
    A.5.4Other Identifiers
    Name:Nederlands Trial RegisterNumber:NTR3982
    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 SponsorAcademisch Medisch Centrum
    B.1.3.4CountryNetherlands
    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 supportZonMW
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademisch Medisch Centrum
    B.5.2Functional name of contact pointEmergency Department
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310205663336
    B.5.5Fax number00310205669191
    B.5.6E-mailm.l.ridderikhof@amc.uva.nl
    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 Paracetamol
    D.2.1.1.2Name of the Marketing Authorisation holderPharmacin B.V.; Molenvliet 103; 3335 LH Zwijndrecht
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 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 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 Diclofenac
    D.2.1.1.2Name of the Marketing Authorisation holderCentrafarm B.V., Etten Leur, Nederland
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameDiclofenac
    D.3.4Pharmaceutical form 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
    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
    D.8 Placebo: 2
    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
    acute musculoskeletal syndromes
    acute musculoskeletale syndromen
    E.1.1.1Medical condition in easily understood language
    Strains and sprains
    Distorsies en kneuzingen
    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 17.1
    E.1.2Level LLT
    E.1.2Classification code 10002182
    E.1.2Term Analgesia
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10033762
    E.1.2Term Paracetamol
    E.1.2System Organ Class 100000004848
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level HLGT
    E.1.2Classification code 10005942
    E.1.2Term Bone and joint injuries
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level HLT
    E.1.2Classification code 10028288
    E.1.2Term Muscle, tendon and ligament injuries
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    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 the study is to compare the effect in treatment of pain with three different strategies of pain management in patients presenting to an Emergency Department and to a general practice with acute musculoskeletal syndromes (defined as musculoskeletal complaints after sustaining an injury with exclusion of a fracture). The strategies of pain management which will be compared are paracetamol, diclofenac and the combination of paracetamol and diclofenac.

    Primaire doel van de studie is het vergelijken van het effect in pijnbestrijding van drie verschillende behandelingsstrategieen bij patienten die zich presenteren op de Spoedeisende Hulp en in een huisartsenpraktijk met acute musculoskeletale syndromen (gedefineerd als musculoskeletale klachten na een trauma, waarbij een fractuur wordt geexcludeerd). De strategieen die vergeleken gaan worden zijn: paracetamol, diclofenac en de combinatie van beiden.
    E.2.2Secondary objectives of the trial
    Secondary objectives of the study are safety of the three different strategies of pain management, patient satisfaction with the treatment and a cost-effectiveness analysis.
    Secundaire doelen zijn veiligheid van de drie verschillende strategieen van pijnbestrijding, patient tevredenheid met de behandeling en een kosten-baten analyse.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - adult (18 years and older) patients
    - presenting to the emergency department of the Academic Medical Centre (AMC) or to a general practice in Amsterdam South-East (Gezondheidscentrum Gein)
    - with traumatic musculoskeletal complaints: isolated, non-penetrating injury of a limb, without a fracture
    - within 48 hours
    - volwassen patienten (18 jaar en ouder)
    - die zich presenteren op de afdeling Spoedeisende Hulp van het AMC of bij Gezondheidscentrum Gein (een huisartsenpraktijk in Amsterdam Zuidoost)
    - met traumatische musculoskeletale klachten: niet-penetrerend extremiteitsletsel, d.w.z. een pijnlijke acute kneuzing of distorsie van een extremiteit
    - minder dan 48 uur voor presentatie
    E.4Principal exclusion criteria
    - previous treatment with analgesia for the same injury
    - self inflicted injury (“auto-mutilation”)
    - presence of wound, joint dislocation, fracture or more then one injury
    - daily use of paracetamol and/or NSAID’s and/or other analgesia within two weeks before presentation
    - patients with chronic pain
    - previous adverse reaction or known allergy to paracetamol, NSAID’s or omeprazol
    - pregnancy
    - previous gastro-intestinal hemorrhage or perforation after NSAID use
    - active or recurrent peptic ulceration or peptic bleeding (2 or more evident episodes)
    - previous exacerbation of asthma after use of NSAID’s or acetylsalicylic acid
    - severe cardiac failure
    - liver cirrhosis
    - severe renal insufficiency (eGFR<30mL/min)
    - bone marrow depression or blood dyscrasia (active or in past medical history)
    - combined use of angiotensin converting enzyme inhibitors (or angiotensin receptor blockers) AND diuretics
    - physical, visual or cognitive impairment or non-Dutch language speaking (unable to use NRS, pain diary or EQ5D questionnaire)
    - eerdere behandeling met pijnstillende medicatie voor hetzelfde letsel
    - letsel door patient bewust toegebracht (automutilatie)
    - aanwezigheid van wond, gewrichtsdislocatie of fractuur
    - dagelijks gebruik van paracetamol en/of nsaid's en/of andere analgetica gedurende de 2 weken voor presentatie
    - patienten met chronische pijn
    - eerdere allergische reactie of overgevoeligheidsreactie op paracetamol, nsaid's of omeprazol
    - zwangerschap
    - eerdere gastro-intestinale bloeding of perforatie na gebruik NSAID's
    - actief of terugkerend ulcus pepticum of gastro-intestinale bloeding (2 of meer episodes)
    - eerdere astma aanval na gebruik van NSAID's of acetylsalicylzuur
    - ernstig hartfalen
    - levercirrose
    - ernstige nierinsufficientie (eGFR<30mL/min)
    - beenmerg depressie of bloed dyscrasie (actief of in de medische voorgeschiedenis)
    - gecombineerd gebruik van angiotensin converting enzyme inhibitors (ACE-remmers) of angtiotensine receptor blokkers EN diuretica
    - fysieke, visuele of cognitieve beperking of niet-Nederlands sprekend (niet in staat tot het uitvoeren van NRS pijnscores in het pijndagboek of het invullen van de EQ5D vragenlijst)
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is decrease in pain, measured by differences in Numeric Rating Scales (NRS). A decrease of 1.3 in NRS is considered clinically relevant. This analgesic effectiveness will be monitored by repetitive measurements of pain scores using the NRS during the stay in the emergency department or during the visit to the general practitioner. After discharge, pain is measured and documented during three consecutive days in the home environment.
    De primaire uitkomst is vermindering in pijn, gemeten in verschillen in Numerical Rating Scales (NRS). Een vermindering van 1.3 in NRS wordt beschouwd als klinisch relevant. Deze analgetische effectiviteit zal gemonitored worden door herhaaldelijke metingen van pijn, gebruik makend van de NRS, gedurende het verblijf van de proefpersoon op de afdeling Spoedeisende Hulp of de huisartsenpraktijk. Na ontslag zal pijn gemeten en gedocumenteerd worden gedurende drie dagen in de thuissituatie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary outcome will be measured at 90 minutes after administration of the study drugs
    De primaire uitkomst zal 90 minuten na toediening studiemedicatie worden gemeten
    E.5.2Secondary end point(s)
    Secondary outcomes are occurrence of adverse events after use of pain medication.The safety profile of the different drugs involved will be investigated by monitoring the occurrence of adverse events in the emergency department or general practice and during a period of three days after discharge. Other secondary outcomes are patient satisfaction about pain relief, need for additional pain medication and cost-effectiveness of the different pain management strategies.
    Special attention is given to the group of patients older then 60 years (block-randomization), as these patients have the highest risk of having NSAID-related adverse events.
    Secundaire uitkomsten zijn het optreden van bijwerkingen na het gebruik van de studiemedicatie. Het veiligheidsprofiel van de verschillende medicijnen zal worden onderzocht door middel van het monitoren van het optreden van bijwerkingen in de huisartsenpraktijk en op de afdeling spoedeisende hulp en gedurende de drie dagen hierna in de thuissituatie. Andere secundaire uitkomsten zijn patienttevredenheid over de pijnbestrijding, behoefte aan additionele pijnmedicatie en kosten-effectiviteitsanalyse van de verschillende pijnbehandelingsstrategieen. Als onderdeel hiervan zal de EQ5D vragenlijst worden ingevuld. Speciale aandacht wordt besteed aan de groep patiënten ouder dan 60 jaar (blok-randomisatie), gezien deze patiënten hoger risico lopen op NSAID-gerelateerde bijwerkingen.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - during stay at emergency department or in general practice at 30 and 60 minutes
    - by using a pain diary at home during three consecutive days after discharge, measuring pain with NRS three times daily (as well as occurrence of adverse events)
    - EQ5D questionnaire once daily during these three days and a final measurement one month after inclusion
    - patient satisfaction at discharge from emergency department or general practice and after three days at home
    - gedurende verblijf op SEH of bij huisarts na 30 of 60 minuten
    - door middel van gebruik van pijndagboekjes in de thuissituatie gedurende drie dagen na ontslag, de patienten meten zelf de pijn met NRS drie keer per dag (evenals het eventuele optreden van bijwerkingen)
    - EQ5D vragenlijst, wordt dagelijks ingevuld gedurende de drie dagen na ontslag en eenmaal 1 maand na inclusie
    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 Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Paracetamol vs Diclofenac vs Paracetamol + Diclofenac
    Paracetamol vs Diclofenac vs Paracetamol + Diclofenac
    E.8.2.4Number of treatment arms in the trial3
    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 concerned2
    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
    Laatste bezoek (telefonisch) contact laatst geincludeerde proefpersoon
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    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: 547
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 547
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2013-05-17. Yes
    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 state547
    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
    geen
    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 Decision2013-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-06
    P. End of Trial
    P.End of Trial StatusCompleted
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