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    Summary
    EudraCT Number:2013-002247-28
    Sponsor's Protocol Code Number:SM2-RS-2013
    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:2013-07-04
    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 number2013-002247-28
    A.3Full title of the trial
    The effect of chlorzoxazone of moderate to severe postoperative pain after back surgery
    Effekten af Chlorzoxazon på moderate til svære postoperative smerter efter rygkirurgi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of the substance Klorzoxazon as pain after back surgery
    Virkningen af stoffet Klorzoxazon som smertebehandling efter rygoperation
    A.4.1Sponsor's protocol code numberSM2-RS-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 pointDepartment of Anaesthesia 4231
    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 number+4535 4595 02
    B.5.5Fax number+4535 4529 50
    B.5.6E-mailjoergen.berg.dahl@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 Chlorzoxazon
    D.2.1.1.2Name of the Marketing Authorisation holderNycomed Danmark
    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.3.1Product nameChlorzoxason
    D.3.4Pharmaceutical form 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 INNCHLORZOXAZONE
    D.3.9.1CAS number 95-25-0
    D.3.9.3Other descriptive nameChlorzoxazon
    D.3.9.4EV Substance CodeSUB06215MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    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
    Patients set to back surgery in general anesthesia
    Patienter indstillet til rygkirurgi i generel anæstesi
    E.1.1.1Medical condition in easily understood language
    Patients set to back surgery in general anesthesia
    Patienter indstillet til rygkirurgi i generel anæstesi
    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 16.0
    E.1.2Level LLT
    E.1.2Classification code 10036236
    E.1.2Term Postoperative pain relief
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Our purpose is to investigate the effect of chlorzoxazone of moderate to severe postoperative pain after spine surgery. Our hypothesis is that chlorzoxazone may reduce postoperative pain, as well as reduce opioidforbrug and adverse reactions compared to placebo.
    Vort formål er, at undersøge effekten af chlorzoxazon på moderate til svære postoperative smerter efter rygkirurgi. Vor hypotese er at chlorzoxazon kan reducere postoperative smerter, samt reducere opioidforbrug og bivirkninger, sammenlignet med placebo.
    E.2.2Secondary objectives of the trial
    Not applicable
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The patient has undergone back surgery in general anesthesia

    Postoperative VAS score of active mobilization defined by standardized movement
    from supine to sitting on the edge of the bed> 50 mm, measured on awakening or
    ward
    Have not received pain medication one hour prior to study entry Age> 18 and <85 years
    ASA 1-3.

    BMI> 18 and <40

    For women of childbearing age requirement they must have a negative urine HCG pregnancy test.
    Patients who have given written informed consent to participate in the study after
    to have understood the contents of the protocol and limitations in full.
    Patienten har gennemgået rygkirurgi i generel anæstesi

    Postoperativ VAS-score i forbindelse med aktiv mobilisation defineret ved standardiseret bevægelse
    fra liggende stilling til siddende på sengekanten > 50 mm, målt på opvågningen eller
    sengeafdelingen
    Har ikke modtaget smertestillende medicin 1 time forud for inklusionen Alder > 18 år og < 85 år
    ASA 1-3.

    BMI > 18 og < 40

    For kvinder i den fertile alder gælder, at de skal have en negativ urin HCG graviditetstest.
    Patienter, som har givet deres skriftlige informerede samtykke til at deltage i undersøgelsen efter
    at have forstået protokollens indhold og begrænsninger fuldt ud.
    E.4Principal exclusion criteria
    Participation in other drug trials
    • Patients who can not understand or speak Danish.
    • Women of childbearing age with positive urine HCG pregnancy test.
    • Allergy to those used in the study drugs.
    • Alcohol and / or drug abuse - the investigator's opinion.
    • Daily consumption of strong opioids (morphine, ketogan, Oxynorm, methadone, fentanyl)
    • Fixed chlorzoxazone treatment.
    • Known or suspected porphyria
    Deltagelse i andet lægemiddelforsøg
    • Patienter, som ikke forstår eller taler dansk.
    • Kvinder i den fertile alder med positiv urin HCG graviditetstest.
    • Allergi over for de i undersøgelsen anvendte stoffer.
    • Alkohol- og/eller medicinmisbrug – efter investigators skøn.
    • Dagligt forbrug af stærke opioider (morfin, ketogan, oxynorm, metadon, fentanyl)
    • Fast chlorzoxazon-behandling.
    • Kendt eller mistænkt porfyri
    E.5 End points
    E.5.1Primary end point(s)
    Pain Score of active mobilization (VAS) defined by standardized movement from supine to sitting on the edge of the bed on time 2 hours after the intake of chlorzoxazone.
    Smertescore i forbindelse med aktiv mobilisation (VAS) defineret ved standardiseret bevægelse fra liggende stilling til siddende på sengekanten til tiden 2 timer efter indtagelse af chlorzoxazon.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 hours after intake of studymedication
    2 timer efter projketmedicinen er indtaget
    E.5.2Secondary end point(s)
    The total need for morphine from 0 to 4 hours after administration of the studymedication administered as patient-controlled pain management (PCA bolus 2.5 mg, lockout 10 minutes) and escape morphine.
    Pain Score at rest (VAS) at time 1, 2, 3 and 4 hours, calculated as the area under the curve (AUC) from 1-4 hours after intake of studymedication.
    Pain Score of active mobilization (VAS) defined by a standardized movement from supine to sitting on the edge of the bed on time 1, 2, 3 and 4 hours, calculated area under the curve from 1-4 hours after intake of studymedication .
    The degree of nausea at time 1, 2, 3 and 4 hours after intake of study medication.
    The degree of dizziness at time 1, 2, 3 and 4 hours after taking the medicine project
    Number of vomiting during the periods 0-4 hours after intake of studymedication.
    consumption of Zofran over the period 0-4 hours after intake of study medication.
    Degree of sedation at time 1, 2, 3 and 4 hours after intake of study medication.
    Det totale behov morfin fra 0 til 4 timer efter indgift af projektmedicin, administreret som patientkontrolleret smertebehandling (PCA, bolus 2,5 mg, lockout 10 minutter) og escape morfin.
    Smertescore i hvile (VAS) til tiden 1, 2, 3 og 4 timer, beregnet som arealet under kurven fra 1-4 timer efter indtagelse af projektmedicin.
    Smertescore i forbindelse med aktiv mobilisation (VAS) defineret ved en standardiseret bevægelse fra liggende stilling til siddende på sengekanten til tiden 1, 2, 3 og 4 timer, beregnet som arealet under kurven fra 1-4 timer efter indtagelse af projektmedicin.
    Graden af kvalme til tiden 1, 2, 3 og 4 timer efter indtagelse af projektmedicin
    Graden af svimmelhed til tiden 1, 2, 3 og 4 timer efter indtagelse af projektmedicin
    Antal af opkastninger i perioderne 0-4 timer efter indtagelse af projektmedicin.
    Zofranforbrug i perioden 0-4 timer efter indtagelse af projektmedicin.
    Graden af sedation til tiden 1, 2, 3 og 4 timer efter indtagelse af projektmedicin.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1,2,3 and 4 hours after intake of study medication
    1,2,3, og 4 timer efter indgift af projektmedicin
    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 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) 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 No
    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
    It is planned to include 110 patients - studydrug will be given when the patient has postoperative pain by mobilisation > 50 mm mesured by VAS
    Der skal inkluderes 110 patienter. Ved postoperative mobilisationssmerter > 50 mm målt vha VAS .
    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 months7
    E.8.9.1In the Member State concerned days12
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 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)
    The Department's standard pain treatment after back surgery.
    Afdelingens standard smertebehandling efter rygkirurgi
    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 Decision2013-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-08-28
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