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    Summary
    EudraCT Number:2015-002694-37
    Sponsor's Protocol Code Number:507A011
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-01-04
    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 ConcernedFinland - Fimea
    A.2EudraCT number2015-002694-37
    A.3Full title of the trial
    Dexmedetomidine infusion in pain management during low back surgery

    Dexmedetomidine is an alpha-2-adrenergic agonist that is used mainly for sedation in the intensive care unit. Alpha-2-adrenoceptors agonists have several beneficial actions in a surgical patient. They decrease symphatetic tone, reduce anesthetic and opioid requirements and cause sedation and analgesia. Pain after low back surgery is intense and can become chronic. We need a new drug to manage pain during postoperative period and to prevent chronic pain.
    DEXPAIN-study has been approved by Kuopio university hospitals ethics committee. Study is single centered, randomized and placebo-controlled study. A total of 60 patients scheduled for low back surgery will be enrolled in this study. Patients eligibility will be assessed by pre-determined inclusion-exclusion-criteria. Purpose of this study is to determine does Dexmedetomidine infusion provide pain management in the postoperative period and prevent chronic pain. Patients are randomized to receive either placebo or dexmedetomidine infusion. Patients in the dexmedetomidine group receive dexmedetomidine loading dose 1ug/kg for 10 minutes and continuous infusion 1.4 ug/kg/h during surgery and post-anesthesia care unit. Total infusion time will be four hours. Anesthesia is standardized and post-operative pain is treated with patient controlled analgesia made of oxycodone. Questionnaires will be used to assess pain control.
    Study is scheduled to start as soon as we obtain permission from Finnish Medicines Agency and receive sufficient funding.
    Deksmedetomidiini on alunperin anestesian esilääkkeeksi kehitetty α2-reseptoriagonisti. Tällä hetkellä sitä käytetään potilaiden lääkinnälliseen sedaatioon. Deksmedetomidiinilla on myös havaittu olevan analgeettisia vaikutuksia. Analgeettinen vaikutus välittyy sekä aivoissa että selkäytimen takasarvessa sijaitsevien α2-adrenoreseptoreiden kautta ja lääkettä on käytetty kivunhoidossa useissa eri tutkimuksissa. Deksmedetomidiinilla on lähinnä kardiovaskulaarisia sivuvaikutuksia. Bradykardia on yleisin haittavaikutus. Deksmedetomidiini ei aiheuta potilaille hengityslamaa. Deksmedetomidiini metaboloituu maksassa ja erittyy munuaisten kautta. Ikä ei vaikuta deksmedetomidiinin farmakokinetiikkaan. Tutkimuksesta suljetaan pois mm. uniapneapotilaat, maksan- ja munuaisten vajaatoimintaa sairastavat potilaat. Selkäkipu on erittäin yleinen vaiva ja melkein kaikki suomalaiset kärsivät selkäkivuista jossain elämänvaiheessa. Suurin osa selkäkivuista paranee itsestään, mutta osalla tilanne pitkittyy ja voi huomattavasti invalidisoida henkilön elämää. Tarve uudelle tehokkaalle kivunhoitomenetelmälle on ilmeinen. Tutkimukseen otetaan selkäleikkaukseen tulevia potilaita ja heidän soveltuvuus tutkimukseen arvioidaan yksilökohtaisesti. Potilaiden soveltuvuutta tutkimukseen arvioidaan ennalta määritellyin mukaanotto ja poissulku-kriteerein. Tutkittavilta pyydetään kirjallinen sopimus tutkimukseen osallistumisesta ja osallistuminen on vapaaehtoista. Potilaat sokkoutetaan tietokoneohjelman avulla saamaan placeboa tai deksmedetomidiini-infuusion kaksi tuntia kestävänä infuusiona leikkauksen aikana ja postoperatiivisesti heräämössä. Leikkauksen jälkeistä kipua hoidetaan oksikodoni-PCA-pumpulla ja parasetamolilla. Tutkimuksen tavoitteena on selvittää voidaanko deksmedetomidiini-infuusion avulla vähentää potilaiden leikkauksen jälkeistä kipua ja vähentää tarvittavien kipulääkkeiden määrää.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dexmedetomidine is a drug that is used mainly for sedation in the intensive care unit. Purpose of this study is to determine does Dexmedetomidine infusion provide pain management in the postoperative period and prevent chronic pain. Patients are randomized to receive either placebo or dexmedetomidine infusion. DEXPAIN-study has been approved by Kuopio university hospitals ethics committee.
    A.4.1Sponsor's protocol code number507A011
    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 SponsorKuopio University hospital
    B.1.3.4CountryFinland
    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 supportKuopio university hospital
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKuopio university hospital
    B.5.2Functional name of contact pointClinic of anesthesiology
    B.5.3 Address:
    B.5.3.1Street AddressPuijonlaaksontie 2
    B.5.3.2Town/ cityKuopio
    B.5.3.3Post code70210
    B.5.3.4CountryFinland
    B.5.6E-mailantti.mykkanen@kuh.fi
    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 Dexmedetomidine
    D.2.1.1.2Name of the Marketing Authorisation holderOrion pharma
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 nameDexdor
    D.3.4Pharmaceutical form Concentrate and solvent for solution for 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 INNDEXMEDETOMIDINE
    D.3.9.1CAS number 113775-47-6
    D.3.9.4EV Substance CodeSUB07037MIG
    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) Yes
    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 placeboConcentrate and solvent for solution for infusion
    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
    Low back pain, Discus prolapse, Spinal stenosis
    E.1.1.1Medical condition in easily understood language
    Patients scheduled for low back surgery will be enrolled in this study
    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
    Purpose of this study is to determine does Dexmedetomidine infusion provide pain management in the postoperative period and prevent chronic pain.
    Tutkimuksen tavoitteena on selvittää voidaanko deksmedetomidiini-infuusion avulla vähentää potilaiden leikkauksen jälkeistä kipua ja vähentää tarvittavien kipulääkkeiden määrää
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients age 18 - < 70 years, BMI 17 - >35 kg/m2, Patient scheduled for lumbar disc surgery
    Ikä > 18 - < 70 vuotta, BMI 17 - >35 kg/m2, Leikkaushoitoa vaativa selkäsairaus
    E.4Principal exclusion criteria
    Age < 18 or > 70 years, BMI < 17 ja >35 kg/m2, Allergic to dexmedetomidine, Renal- or liver impairment, Sleep apnea syndrome, chronic pain
    Ikä < 18 tai > 70 vuotta, BMI < 17 ja >35 kg/m2, allegia deksmedetomidiinille, Munuaisten tai maksan vajaatoiminta, Uniapnea, Krooninen kipu
    E.5 End points
    E.5.1Primary end point(s)
    Post-operative oxycodone consumption
    Leikkauksenjälkeinen oksikodonin kulutus
    E.5.1.1Timepoint(s) of evaluation of this end point
    First and Second postoperative day
    Ensimmäinen ja toinen leikkauksenjälkeinen päivä
    E.5.2Secondary end point(s)
    Pain one month after surgery
    Koettu kipu kuukauden päästä leikkauksesta
    E.5.2.1Timepoint(s) of evaluation of this end point
    one month after surgery
    Kuukausi leikkauksen jälkeen
    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) 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 Yes
    E.8.1.4Double blind No
    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
    Trial is ended after 1 month follow up
    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 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: 60
    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 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 state60
    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)
    Treatment after the trial is not different from normal treatment of that condition
    Potilaiden hoito tutkimuksen jälkeen ei eroa tavanomaisesta hoidosta
    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 Decision2016-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-01
    P. End of Trial
    P.End of Trial StatusOngoing
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