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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2014-005416-42
    Sponsor's Protocol Code Number:KF001
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-03-12
    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 ConcernedSweden - MPA
    A.2EudraCT number2014-005416-42
    A.3Full title of the trial
    Clondine in repeated doses for children in pain - a farmacokinetic study
    Klonidin i upprepade doser för barn med smärta - en farmakokinetisk studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clonidine in repeated doses for children in pain
    Klonidin i upprepade doser för barn med smärta
    A.4.1Sponsor's protocol code numberKF001
    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 SponsorUppsala University. Department of Women's and children's health
    B.1.3.4CountrySweden
    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 supportThe Swedish Childhood Cancer Foundation
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUppsala university, Department of Women's and children's health
    B.5.2Functional name of contact pointKlonidinstudien
    B.5.3 Address:
    B.5.3.1Street AddressGustaf Ljungman, Akademsiska barnsjukhuset, barnonkologen 95A
    B.5.3.2Town/ cityUppsala
    B.5.3.3Post codeSE 75185
    B.5.3.4CountrySweden
    B.5.4Telephone number46018611 5804
    B.5.6E-mailgustaf.ljungman@kbh.uu.se
    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 Catapresan
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameCatapresan
    D.3.4Pharmaceutical form Solution for injection/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 INNClonidine
    D.3.9.1CAS number 4205-91-8
    D.3.9.3Other descriptive nameCLONIDINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB01362MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 No
    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 nameKlonidin APL
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Yes
    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 INNClonidine
    D.3.9.1CAS number 4205-91-8
    D.3.9.3Other descriptive nameCLONIDINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB01362MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pain in children
    Smärta hos barn
    E.1.1.1Medical condition in easily understood language
    Pain in children
    Smärta hos barn
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10033371
    E.1.2Term Pain
    E.1.2System Organ Class 10018065 - General disorders and administration site conditions
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. What is the bioaavailaiblity of mixture klonidine 20 ug/ml in children?
    2. Does the area under the curve correlate to the weight/body area of the child?
    3. What is the through value when clondine 1 ug/kg is administred every sixth hour?
    1. Vilken biotillgänglighet har mixtur klonidin 20 mikrogram/kg hos barn och ungdomar?
    2. Korrelerar plasmakoncentrationen av klonidin till barnets vikt och/eller kroppsarea?
    3. Vilken är dalkoncentration av klonidin när det ges i dosen 1 mikrogram/kg var sjätte timme till barn och ungdomar.
    E.2.2Secondary objectives of the trial
    4. Does the area under the curve correlate to the child’s pain?
    5. Does the area under the curve correlate to the child’s sedation level?
    6. Does the area under the curve correlate to the child's opioid need?
    4. Korrelerar ytan under kurvan med graden av smärta som barnet upplever?
    5. Korrelerar ytan under kurvan med barnets sederingsgrad?
    6. korrelerar ytan under kurvan med barnets behov av opioider?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age 6 month-18 years
    Admitted to the oncology and hematology ward at Uppsala University Childrens hospital.
    clonidine 1 ug/kg x 4 prescribed by responsible doctor.
    Ålder 6 månader -18 år
    Vårdas på avd. för blod och tumörsjukdomar, Akademiska Barnsjukhuset
    Ordinerats klonidin 1 ug/kg x 4 av sin ansvariga läkare
    E.4Principal exclusion criteria
    Temperature >39 degrees celcius
    sepsis
    Poor swedish language skills
    Feber > 38.5 grader
    sepsis
    Bristfälliga svenskakunskaper
    E.5 End points
    E.5.1Primary end point(s)
    1. Clonidine concentration in blood
    Koncentration klonidin i blodet
    E.5.1.1Timepoint(s) of evaluation of this end point
    10,20,30,60,120,240 min after first dose. Prior to morning dose the following days
    10,20,30,60,120,240,360 min efter första dosen. Innan morgondosen kommande dagar
    E.5.2Secondary end point(s)
    2. Pain
    Children- 4-6 år - Facial pain scale revisited (FPS-r)
    Children- >6 numerical rating scale (NRS)
    Parents- NRS
    Nurse - Face leg arm cry consolability (FLACC)

    3. Sedation
    Nurse -University of Michigan Sedation Scale

    4. opioid consumtion/day (morphine eqvivalents)
    5. side effects of treatment.
    Parents and children -"Questionnaire"
    2. Smärta
    Barn 4-6 år - FPS-r
    Barn > 6 år - NRS
    Samtliga föräldrar - NRS
    Ansvarig sjuksköterska - FLACC

    3. Sedering
    Ansvarig sjuksköterska - University of Michigan Sedation scale
    4. Opioidkonsumtion/dag (morfin ekvivalenter)
    5. Biverkningar av behandlingen.
    Barn och föräldrar - Frågeformulär
    E.5.2.1Timepoint(s) of evaluation of this end point
    2: 0,60,120 and 240 min after fist dose. Before each new dose and 90 minutes after each given dose
    3: 0,60,120 and 240 min after fist dose. Before each new dose.
    4: daily
    5. Daily
    2: 0,60,120, 240 min efter första dosen. Innan varje ny given dos samt 90 minuter efter varje given dos.
    3: 0,60,120, 240 min efter första dosen. Innan varje ny given dos.
    4: Dagligen
    5. Dagligen
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    E.8.1.1Randomised No
    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 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 No
    E.8.2.3Other No
    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
    Last dose IMP given to the last subject
    Sista dosen av prövningsläkemedlet givet till sista deltagaren i studien
    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 Yes
    F.1.1Number of subjects for this age range: 30
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 30
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 30
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children 6 months-18 will be eligible. Parents will give consent for all children and all children who are capable will in addition give their assent.
    Barn mellan 6 månader och 18 år kommer vara aktuella för deltagande i studien. Alla föräldrar/vårdnadshavare kommer ge skriftligt godkännande till deltagandet och alla barn som är kapabla kommer att ge sitt samtycke
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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)
    If the treatment proves to be useful for an individual, they will be offered this treatment in the future.
    Om deltagare upplever att behandlingen gjort nytta kommer deltagare att erbjudas samma behandling i framtiden
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-05-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-01
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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