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    Summary
    EudraCT Number:2016-001056-22
    Sponsor's Protocol Code Number:NDOL-001-2016
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-05-24
    Trial results View 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 ConcernedAustria - BASG
    A.2EudraCT number2016-001056-22
    A.3Full title of the trial
    Neodolpasse® Infusion Solution versus diclofenac 75 mg infusion in the treatment of postoperative pain after elective knee surgery - an exploratory placebo-controlled clinical study to investigate the analgesic properties of the combination of diclofenac and orphenadrine versus diclofenac alone.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Neodolpasse® Infusion Solution versus diclofenac 75 mg infusion in the treatment of postoperative pain after elective knee surgery - an exploratory placebo-controlled clinical study to investigate pain relieve of the combination of diclofenac and orphenadrine versus diclofenac alone.
    A.3.2Name or abbreviated title of the trial where available
    Neodolpasse® versus Diclofenac 75 mg infusion for postoperative pain treatment
    A.4.1Sponsor's protocol code numberNDOL-001-2016
    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 SponsorMedical Univerity Vienna
    B.1.3.4CountryAustria
    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 supportMedical Univerity Vienna
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Clinic for Anaesthesiology, Medical Univerity Vienna
    B.5.2Functional name of contact pointPrinciple Investigator
    B.5.3 Address:
    B.5.3.1Street AddressWaehringer Guertel 18-20
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number0043140400 41030
    B.5.5Fax number0043140400 41040
    B.5.6E-mailoliver.kimberger@meduniwien.ac.at
    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 Neodolpasse-Infusionslösung
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Austria GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameNeodolpasse-Infusionslösung
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdiclofenac-sodium
    D.3.9.1CAS number 15307-79-6
    D.3.9.3Other descriptive nameDICLOFENAC
    D.3.9.4EV Substance CodeSUB07092MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOrphenadrine citrate
    D.3.9.1CAS number 4682-36-4
    D.3.9.2Current sponsor codeOrphenadrine citrate
    D.3.9.3Other descriptive nameN,N-dimethyl-2-[(2-methylphenyl)-phenyl-methoxy]ethanamine
    D.3.9.4EV Substance CodeSUB09471MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 VOLTAREN® 75mg/3 ml
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 75 mg
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdiclofenac-sodium
    D.3.9.1CAS number 15307-79-6
    D.3.9.3Other descriptive nameDICLOFENAC
    D.3.9.4EV Substance CodeSUB07092MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 placeboInfusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    major elective knee surgery (cruciate ligament surgery)
    E.1.1.1Medical condition in easily understood language
    planned knee surgery either for mending cruciate ligament rupture
    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
    Trial objective is to investigate the use of additional analgesic medication via PCA during the first 24 hours postoperatively.
    E.2.2Secondary objectives of the trial
    Assessment of the local and systemic tolerability and safety of the clinical study medications (i.e. Neodolpasse® Infusion Solution and 75 mg diclofenac only infusion).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General enrolment criteria are:
    - Elective knee surgery (cruciate ligament surgery)
    - Confirmed patient suitability for planned surgery
    - Age 18 to ≤ 85 years
    - Legally valid signed written informed consent provided
    - Female patients are confirmed non-pregnant or not breast feeding
    - Adequate renal function defined by a creatinine value lower than 1.80 mg/dL for male and ower than 1.50 mg/dL for female patients
    - No known intolerabilities / hypersensitivities to any part of the study medication
    - No reoperation/revision within 6 months after the initial surgery
    - Absence of history of abuse of analgesics or other drug
    - No analgesics within 48 hours prior to surgery (surgery-related excluded)
    - No current / recent (within 4 weeks prior to enrollment) experimental treatment
    - No current / recent (within 4 weeks prior to enrollment) participation in another clinical study
    - No foreseeable difficulties with regard to protocol compliance

    IMP-related enrollment criteria are:
    - Known hypersensibility against the active ingredients diclofenac or orphenadrine
    - Known hypersensibility against the other ingredients of the investigational medicinal product
    - Absence of congestive heart failure classes 2 or higher according to the NYHA classification
    - Absence of ischemic heart disease
    - Absence of peripheral arterial occlusive disease
    - Absence of cerebro-vascular disease
    - Absence of significant risk factors for cardiovascular events (e.g., hypertension, hyperlipidaemia, type-2 diabetes, moderate smoking)
    E.4Principal exclusion criteria
    Please refer to list of principal inclusion criteria (=enrolment criteria) for details.
    E.5 End points
    E.5.1Primary end point(s)
    - Total dose of analgesic delivered by PCA over the first 48 hours post-surgery
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Total PCA dose: during first 48 hours post-surgery
    E.5.2Secondary end point(s)
    - Pain intensity assessed during the first 48 hours after the surgical intervention by using a Visual Analogue Scale (VAS) with focus on the infusion periods

    - Total dose of analgesic delivered by PCA over the first 8 and 16 hours post-surgery

    - Delirium state of the study patients assessed by Delirium Detection Score for Orphenadrine safety

    - Laboratory safety values, vital signs and adverse event profile until 48 hours post-surgery to assess overall safety and tolerability of IMP
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Pain intensity (VAS): until 48 hours post-surgery (end of follow-up)
    - Total PCA dose: until 48 hours post-surgery (end of follow-up)
    - Delirium state: 4 hours after start of every IMP infusion
    - Laboratory safety values: at registration/randomization and until 48 hours post-surgery (end of follow-up)
    Vital signs: at registration/randomization
    Adverse event profile: until 48 hours post-surgery (end of follow-up)
    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 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) 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 No
    E.8.2.4Number of treatment arms in the trial3
    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 years0
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months12
    E.8.9.2In all countries concerned by the trial 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: 52
    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 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 state72
    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)
    There will be no specific post trial treatment. All study patients will receive treatment according to the established medical practice.
    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 Decision2016-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-05-20
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