Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   36111   clinical trials with a EudraCT protocol, of which   5936   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).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2019-000205-77
    Sponsor's Protocol Code Number:KF5503-75
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2019-06-28
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2019-000205-77
    A.3Full title of the trial
    Open-label investigation of the pharmacokinetic profile, safety, tolerability, and efficacy of multiple administrations of tapentadol oral
    solution used for treatment of acute pain in children aged 2 years to less than 7 years
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to find out how much tapentadol is in the blood of children who take tapentadol every 4 hours to treat short-term pain
    A.4.1Sponsor's protocol code numberKF5503-75
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1225-7869
    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 SponsorGrünenthal GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGrünenthal GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGrünenthal GmbH
    B.5.2Functional name of contact pointGrünenthal Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressZieglerstr. 6
    B.5.3.2Town/ cityAachen
    B.5.3.3Post code52078
    B.5.3.4CountryGermany
    B.5.4Telephone number492415693223
    B.5.6E-mailClinical-Trials@grunenthal.com
    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 Palexia 4 mg/ml oral solution
    D.2.1.1.2Name of the Marketing Authorisation holderGrünenthal Ltd., United Kingdom
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 namePalexia 4 mg/ml oral solution
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation No
    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 INNTapentadol
    D.3.9.1CAS number 175591-09-0
    D.3.9.3Other descriptive nameTAPENTADOL HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB32145
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.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 Palexia 20 mg/ml oral solution
    D.2.1.1.2Name of the Marketing Authorisation holderGrünenthal Ltd., United Kingdom
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 namePalexia 20 mg/ml oral solution
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation No
    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 INNTapentadol
    D.3.9.1CAS number 175591-09-0
    D.3.9.3Other descriptive nameTAPENTADOL HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB32145
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(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
    Moderate to severe acute pain
    E.1.1.1Medical condition in easily understood language
    Moderate to severe acute pain following a painful event e.g. an operation
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10066714
    E.1.2Term Acute pain
    E.1.2System Organ Class 100000004867
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the pharmacokinetic profile of tapentadol after the administration of multiple doses of tapentadol oral solution to
    children aged 2 years to less than 7 years after a painful event that routinely produces acute pain requiring treatment with a strong
    analgesic medication (e.g., opioids or metamizole).
    E.2.2Secondary objectives of the trial
    To investigate the pharmacokinetic profile of tapentadol-O-glucuronide after the administration of multiple doses of tapentadol oral solution to children aged 2 years to less than 7 years after a painful event that routinely produces acute pain requiring treatment with a strong analgesic medication (e.g., opioids or metamizole).
    To investigate the pharmacokinetic profile of tapentadol-O-sulphate after the administration of multiple doses of tapentadol oral solution to children aged 2 years to less than 7 years after a painful event that routinely produces acute pain requiring treatment with a strong analgesic medication (e.g., opioids or metamizole).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Informed consent, and if applicable assent, given according to local regulations.
    - The subject is male or female and aged 2 years to less than 7 years from the time of allocation to investigational medicinal product (IMP) until End of Treatment and Evaluation Visit (Visit 3).
    - The subject experienced a painful event (e.g., a painful intervention or surgery) that, in the investigator’s opinion, would reliably produce acute pain requiring treatment with a strong analgesic (e.g., opioids or metamizole) for at least 24 hours after Dose 1. The subject is expected to remain hospitalized until Visit 3.
    - The subject is able to tolerate liquids at the time of allocation to IMP.
    - The subject has a reliable venous vascular access or can be venipunctured repeatedly for pharmacokinetic blood sampling, depending on which is less burdensome for the individual subject.
    E.4Principal exclusion criteria
    - The subject, their parent, or their legal representative is an employee of the investigator or trial site, with direct involvement in the proposed trial or other trials under the direction of that investigator or trial site, or is a family member of the employees or the investigator.
    - The subject has been exposed to tapentadol 28 days or less before enrollment.
    - The subject has received an experimental drug 28 days or less before allocation to IMP or, if 10 half-lives of the drug are longer than 28 days, 10 half-lives of the drug or less before allocation to IMP.
    - The subject participates concurrently in another clinical trial with an experimental drug.
    - The subject has undergone brain surgery.
    - The subject has undergone an intervention or surgery that will, in the opinion of the investigator, affect the absorption of tapentadol (e.g., surgery of the gastrointestinal tract).
    - The subject has signs or symptoms of congestive heart failure (e.g., requiring more than minimal inotropic support), or hemorrhagic disorder following surgery.
    - The subject has (a history of) any of the following:
    • Seizure disorder or epilepsy.
    • Renal or hepatic impairment.
    • Acute or severe bronchial asthma or hypercapnia.
    • Brain tumors, clinically relevant history or a current condition of head injury, or increased intracranial pressure including traumatic and hypoxic brain injuries such as stroke, transient ischemic attack, brain contusion, intracranial hematoma, episode(s) of more than 24 hours duration of unconsciousness, or posttraumatic amnesia.
    - The subject has biliary tract disease or has or is suspected of having paralytic ileus.
    - The subject has a disease or disorder (e.g., impaired respiratory function or clinically relevant respiratory disease, endocrine, metabolic, neurological, psychiatric, infection, febrile seizure, clinically relevant abnormal electrocardiogram [ECG]) that, in the opinion of the investigator, may affect or compromise the subject’s safety during participation in the trial.
    - The subject is obese, i.e., has a body mass index (BMI) equal to or above the 95th percentile for children based on the World Health Organization (WHO) BMI charts.
    - The subject has a body weight below 9.0 kg.
    - The subject has a clinically relevant history of hypersensitivity, allergy, or contraindication to tapentadol, or the excipients (see the summary of product characteristics [SmPC]), or naloxone.
    - The subject is mentally retarded, cognitively impaired, or unable to comprehensively understand or follow the trial instructions as appropriate for the age of the subject, based on medical history and/or in the judgment of the investigator.
    - The subject is taking prohibited concomitant medication.
    - The subject will be excluded if any of the following criteria applies for local safety laboratory results:
    • Aspartate transaminase and/or alanine transaminase is above 3 times upper limit of normal.
    • Total bilirubin is above 2 times upper limit of normal.
    • Glomerular filtration rate (GFR) is below 60 mL/min (calculated according to Schwartz et al. 1984).
    • Lactic acid value is above 2 times upper limit of normal (only if the painful event was cardiac surgery).
    • Any other parameter is, in the judgment of the investigator, clinically significant and would put the subject at undue risk if they were to take part in the trial.
    - The subject will be excluded if any of the following criteria is met at the time of allocation to IMP:
    • The subject has, in the judgment of the investigator, clinically unstable systolic and diastolic blood pressure, heart rate, respiratory depression, or clinically unstable upper or lower airway conditions, or a clinically significant decreased/unstable saturation of peripheral oxygen (SpO2).
    • The subject requires continuous positive airway pressure or mechanical ventilation.
    E.5 End points
    E.5.1Primary end point(s)
    Area under the concentration-time curve at steady state for the dosing interval (AUCtau,SS) for tapentadol
    E.5.1.1Timepoint(s) of evaluation of this end point
    From 1.5 hours after Dose 1 (Day 1) until 10 hours after the final dose (Day 4)
    E.5.2Secondary end point(s)
    Area under the concentration-time curve at steady state for the dosing interval (AUCtau,SS) for tapentadol-O-glucuronide
    Area under the concentration-time curve at steady state for the dosing interval (AUCtau,SS) for tapentadol-O-sulphate
    E.5.2.1Timepoint(s) of evaluation of this end point
    From 1.5 hours after Dose 1 (Day 1) until 10 hours after the final dose (Day 4)
    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 Yes
    E.6.6Pharmacokinetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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.8.2.4Number of treatment arms in the trial1
    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.8.4.1Number of sites anticipated in Member State concerned3
    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 years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days8
    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: 15
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 15
    F.1.1.6Adolescents (12-17 years) No
    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
    The informed consent discussion will be conducted with the parent(s) or legal guardian(s) who will provide written informed consent.
    If applicable, the child will sign an assent form.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    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)
    Standard of care
    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 Decision2019-06-26
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA