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    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2017-002167-18
    Sponsor's Protocol Code Number:FK_0001
    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:2017-07-12
    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 number2017-002167-18
    A.3Full title of the trial
    INTRANASAALINEN FENTANYYLI JA S-KETAMIINI AKUUTIN KIVUN HOIDOSSA PIENTRAUMAPOTILAILLA
    INTRANASAALINEN FENTANYYLI JA S-KETAMIINI AKUUTIN KIVUN HOIDOSSA PIENTRAUMAPOTILAILLA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Nenäsuihkeena käytettävät vahvat kipulääkkeet vammakivun hoidossa
    Nenäsuihkeena käytettävät vahvat kipulääkkeet vammakivun hoidossa
    A.4.1Sponsor's protocol code numberFK_0001
    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 SponsorAnna Meuronen
    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 supportHelsingin ja Uudenmaan sairaanhoitopiiri
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHelsingin ja Uudenmaan sairaanhoitopiiri
    B.5.2Functional name of contact pointAkuutti, Hyvinkään sairaala
    B.5.3 Address:
    B.5.3.1Street AddressSairaalankatu 1
    B.5.3.2Town/ cityHyvinkää
    B.5.3.3Post code05850
    B.5.3.4CountryFinland
    B.5.4Telephone number+358(0)1945 871
    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 Fentanyl 50 mikrog/ml injektioliuos
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag Oy, ESPOO, Suomi / B. Braun Melsungen AG, MELSUNGEN, Saksa
    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.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNfentanyylisitraatti
    D.3.9.3Other descriptive nameFENTANYL CITRATE
    D.3.9.4EV Substance CodeSUB02129MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Ketanest-S 25 mg/ml liuos
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Oy, HELSINKI, Suomi
    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.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNesketamiinihydrokloridi
    D.3.9.3Other descriptive nameESKETAMINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB25811
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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/infusion
    D.8.4Route of administration of the placeboIntranasal use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Akuutti kipu
    E.1.1.1Medical condition in easily understood language
    Akuutti kipu
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10066714
    E.1.2Term Acute pain
    E.1.2System Organ Class 100000023314
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Tutkimuksen tavoitteena on parantaa kivunhoitoa päivystyksessä pientraumapotilailla.
    E.2.2Secondary objectives of the trial
    Tässä tutkimuksessa arvioidaan soveltuuko intranasaalinen fentanyyli ja S-ketamiini kovan kivun hoitoon päivystyksessä polikliinisilla aikuisilla pientraumapotilailla. Tähän pyritään vertaamalla S-ketamiinia ja fentanyylia toisiinsa sekä lumelääkkeeseen ylä- ja alaraajavamman saaneilla potilailla päivystykseen tullessa sekä tarvittaessa vammaan liittyvän pientoimenpiteen aikana. Potilaille ei yleensä tätäkään varten avata iv-yhteyttä ja suun kautta otettava vahvempi kipulääkitys ei välttämättä ehdi auttaa tai sitä ei ylipäänsä annettaisi. Tutkimuksen tavoitteena on parantaa kivunhoitoa päivystyksessä pientraumapotilailla.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ikä 18-80 vuotta, paino 45-115 kg, ylä- tai alaraajan vamma, ei välitöntä tarvetta iv-yhteydelle ja NRS ≥5.
    E.4Principal exclusion criteria
    raskaus, imetys, vaikea COPD, vaikea munuaisten vajaatoiminta (edellinen gfr < 30), maksakirroosi, merkittävä psyykkinen sairaus (ei sisällä lievää tai kohtalaista masennusta), uniapnea, oireinen sepelvaltimotauti tai sydämen vajaatoiminta, hoitamaton glaukooma, GCS < 15, päihtymys, verenpaine yli 180/115 tai alle 100/, syke alle 50, Spo2 alle 95% huoneilmalla, dementia, kielimuuri, yliherkkyys tutkituille lääkeaineille, jo käytössä oleva opioidilääkitys, este antaa nenäsuihketta, pään vamma tai hoitavan lääkärin arvio sopimattomuudesta tutkimukseen
    E.5 End points
    E.5.1Primary end point(s)
    Primääriset päätemuuttujat tutkimuksen ensimmäisessä osassa ovat NRS lasku sekä tarve oksikodonille. Tutkimuksen toisessa toimenpiteen aikaisessa lääkitysosiossa primäärinen päätemuuttuja on NRS muutos toimenpiteen aikana.
    E.5.1.1Timepoint(s) of evaluation of this end point
    15 ja 30 minuuttia ensimmäisestä lääkeannoksesta sekä toimenpiteeseen liittyen toimenpiteen aikainen muutos NRS:ssa.
    E.5.2Secondary end point(s)
    Sekundäärinen on potilaiden osuus, joilla NRS laskee ≥2, potilaiden tyytyväisyys kivun hoitoon, tutkimuslääkkeen kokonaismäärä, haitat ja kokonaiskokemus kivunhoidosta hoitojaksolla.

    Sekundääriset päätemuuttujat toimenpiteen osalta ovat potilaan tyytyväisyys kivun hoitoon ja haitat
    E.5.2.1Timepoint(s) of evaluation of this end point
    15, 30 ja 60 minuuttia sekä mahdollisen toimenpiteen aikana ja 15 minuuttia jälkeen, kotiutuessa/120 min ensimmäisestä lääkeannoksesta
    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 No
    E.8.2.4Number of treatment arms in the trial2
    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.8.5The 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
    Tutkimus on kertatutkimus eli tutkimus potilaan osalta päättyy samalla päivystyskäynnillä kuin alkaakin potilaan kotiutuessa.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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: 65
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 2017-07-12. 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 Yes
    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 state105
    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)
    Potilas jatkaa vammansa vaatiman hoidon normaalin kliinisen käytännön mukaan.
    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 Decision2017-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-19
    P. End of Trial
    P.End of Trial StatusOngoing
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