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    Summary
    EudraCT Number:2018-001221-98
    Sponsor's Protocol Code Number:1.3
    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:2018-05-14
    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 number2018-001221-98
    A.3Full title of the trial
    DEXAMETHASONE AS ADJUVANT FOR PERIPHERAL NERVE BLOCKADE: A RANDOMIZED, TRIPLE-BLINDED AND CROSSOVER STUDY IN VOLUNTEERS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dexamethasone mixed with a local anaesthetic in different combination: a randomized, triple-blinded and crossover study in volunteers
    A.3.2Name or abbreviated title of the trial where available
    Dexamethason adjuvant study
    A.4.1Sponsor's protocol code number1.3
    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 University of Vienna, Department of Clinical Pharmacology
    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 University of Vienna, Department of Clinical Pharmacology
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Vienna, Department of Anaesthesia, Intensive Care and Pain Medicine
    B.5.2Functional name of contact pointDaniela Marhofer
    B.5.3 Address:
    B.5.3.1Street AddressSpitalgasse 23
    B.5.3.2Town/ city1090
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number+4314040041030
    B.5.5Fax number+4314040041040
    B.5.6E-maildaniela.marhofer@meduniwien.ac.at
    D. IMP Identification
    D.IMP: 1
    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 Dexabene
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA B.V.
    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 namedexamethason
    D.3.2Product code 1-20848
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPLocal use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdexamethason
    D.3.9.1CAS number 50-02-2
    D.3.9.3Other descriptive nameDEXAMETHASONE DIHYDROGEN PHOSPHATE DISODIUM PH. EUR.
    D.3.9.4EV Substance CodeSUB176825
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 placeboSolution for injection
    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
    The combination of local anaesthetics plus dexamethasone shall increase the duration of regional anaesthetic blocks. It is a volunteers´study. Three different block combination are performed. One block is performed with naropin as a single dose, one block with naropin and dexamethasone perineural and one block with naropin and dexamethason intravenous. Pinprick test and thumb adduction are performed for evaluation block success.
    E.1.1.1Medical condition in easily understood language
    This volunteers´study should evaluate 3 different combinations of 2 medical drugs to achieve a prolonged regional anesthetic block. Every block is received in every vonlunteer with a break of 1 week.
    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
    To evaluate the impact of perineural dexamethasone on duration of sensory nerve blockade with clinical testing
    E.2.2Secondary objectives of the trial
    To evaluate the impact of perineural dexamethasone on sensory and motor onset times and the duration of motor blockade.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Healthy males
    • Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by the Investigator/Sub-Investigator
    • Signed written informed consent prior to inclusion in the study
    • 18-55 years old inclusive
    • Clearly detectable ulnar nerve at the non-dominant arm in ultrasound evaluation, according to the main investigators opinion (P.M.)
    • BMI: 18 to 35 kg/m2
    • Ability to understand the full nature and purpose of the study, including possible risks and side effects
    • Ability to co-operate with the investigator and to comply with the requirements of the entire study
    • Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements
    E.4Principal exclusion criteria
    • Any clinically relevant abnormalities at ECG (12 leads)
    • Any clinically relevant abnormal physical findings
    • Any clinically relevant abnormal laboratory values indicative of physical illness
    • Ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients of the study drug
    • History of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study
    • If one of the investigated nerves are not clearly visible in ultrasound
    • Relevant history of malignancy, of renal, hepatic, cardiovascular, respiratory, gastrointestinal, musculoskeletal, skin (particularly at the site of drug application), haematological, endocrine or neurological diseases that may interfere with the aim of the study
    • Any psychiatric illnesses
    • Using other medications during 1 week before the start of IMP application including OTC
    • Participation in another clinical study investigating another IMP within 1 month prior to screening
    • Blood donations during 4 weeks prior to this study History of drug or alcohol abuse (>2 drinks/day, defined according to USDA Dietary Guidelines 2015)
    • Other objections to study participation in the opinion of the investigator
    E.5 End points
    E.5.1Primary end point(s)
    After performing the block the volunteers are tested motor and sensory block success at baseline, 2, 4, 6, 8, 10, 15, 20, 30, 60 min after the block, and then every 30 min until complete recovery.
    Motor blockade will be assessed via adduction of the thumb:
    - 3 = no difference, adduction against contra-force possible
    - 2 = slight difference, adduction against slight contra-force hardly possible
    - 1 = significant difference, adduction without contra-force hardly possible
    - 0 = no active adduction possible, paralysis

    Sensory blockade will be assessed via Pinprick testing at the hypothenar area in comparison with the contralateral side. Five areas of sensory supply are defined:
    - dorsal side hypothenar muscles
    - ulnar side hypothenar area
    - palmar side hypothenar muscles
    - fifth finger
    - ulnar side fourth finger.
    "0" means 0% sensory, 100% means complete sensory.
    Duration of sensory and motor block is defined as Pinprick = 20 in the hypothenar area and motor scale = 1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Motor and sensory block success are tested at baseline, 2, 4, 6, 8, 10, 15, 20, 30, 60 min after the block, and then every 30 min until complete recovery.
    E.5.2Secondary end point(s)
    The final visit at the end of the study takes place by a telephone call to evaluate ulnar nerve function and puncture site of the nerve block.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The phone call will be performed up to 7 days after the last study period.
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    triple-blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Ropivacain in combination with or without Dexamethasone perineuronale or intravenous
    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
    When sensibility and motor function completeley recovered, the
    volunteer is able to be discharged from Phase 1. A total of three phases are planned. The volunteer has to come for a final
    visit within 1 week. After this meeting the study is finished.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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: 24
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state24
    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)
    It is a voluntter study. No further treatment is necessary. If side effects
    occur there is either a medical doctor or a 24hours telephone hotline of
    the hospital available.
    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 Decision2018-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-16
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