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    Summary
    EudraCT Number:2012-004359-35
    Sponsor's Protocol Code Number:R331333PAI3037
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-12-10
    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 ConcernedCzech Republic - SUKL
    A.2EudraCT number2012-004359-35
    A.3Full title of the trial
    An evaluation of the efficacy and safety of tapentadol oral solution in the treatment of post-operative acute pain requiring opioid treatment in pediatric subjects aged from birth to less than 18 years old.
    Hodnocení účinnosti a bezpečnosti tapentadolu ve formě perorálního roztoku při léčbě akutní pooperační bolesti vyžadující léčbu opioidy u pediatrických pacientů ve věku od narození do 18 let.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to look at Tapentadol Oral Solution in Children and Adolescents in pain after Surgery
    Studie pro zjištění působení perorálního roztoku tapentadolu k odstranění pooperační bolesti u dětí a adolescentů
    A.3.2Name or abbreviated title of the trial where available
    TAMO
    TAMO
    A.4.1Sponsor's protocol code numberR331333PAI3037
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02081391
    A.5.4Other Identifiers
    Name:INDNumber:108134
    Name:Grünenthal Number:KF5503/65
    Name:DepomedNumber:R331333PAI3037
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/090/2016
    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.4.1Name of organisation providing supportDepomed Inc.
    B.4.2CountryUnited States
    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 number+49241569 3223
    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 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 nameTapentadol 4 mg/mL oral solution
    D.3.2Product code CG5503/R331333
    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 hydrochloride
    D.3.9.1CAS number 175591-09-0
    D.3.9.2Current sponsor codeCG5503/R331333
    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 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 nameTapentadol 20 mg/mL oral solution
    D.3.2Product code CG5503/R331333
    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 hydrochloride
    D.3.9.1CAS number 175591-09-0
    D.3.9.2Current sponsor codeCG5503/R331333
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The management of acute postoperative pain in hospitalized paediatric patients.
    E.1.1.1Medical condition in easily understood language
    A study to look at Tapentadol Oral Solution in Children and Adolescents in pain after Surgery
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10054711
    E.1.2Term Postoperative pain
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10036236
    E.1.2Term Postoperative pain relief
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Efficacy of tapentadol oral solution, based on the total amount of supplemental opioid analgesic medication (morphine equivalents in mg/kg body weight) used within the first 24 hours after first IMP intake.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of tapentadol oral solution using multiple subjective and objective measures of the subject’s response to treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent, and if applicable assent, given according to local regulations.
    2. Male or female subject aged from birth to less than 18 years.
    3. A female subject must be pre-menarchal, or surgically incapable of childbearing, or sexually abstinent, or if a female subject is sexually active, then she must be practicing an effective method of birth control (e.g., prescription hormonal contraceptives, intra-uterine devices used according to the product’s instruction, double-barrier methods) before trial entry and throughout the trial.
    4. female subject must have a negative pregnancy test if aged 12 years or older, or is post-menarchal, or is sexually active.
    5. Subject has undergone surgery (other than brain surgery or gastrointestinal surgery expected to affect the absorption of tapentadol [in the investigator’s judgment]) that, in the investigator’s opinion, would reliably produce moderate to severe pain requiring opioid treatment for at least 24 hours after first dose of IMP. Subjects must remain hospitalized until the End of Treatment Visit.
    6. Subject has received post-operative morphine or hydromorphone by NCA/PCA, with or without a background infusion of the same opioid, according to standard of care prior to allocation/randomization to IMP and subject is expected to require this morphine or hydromorphone by NCA/PCA after starting IMP.
    7. Subject is able to tolerate liquids at the time of allocation/randomization to IMP.
    E.4Principal exclusion criteria
    1. Subject, parent or the 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 family member of the employees or the investigator.
    2. Subject has been previously exposed to tapentadol.
    3. Subject has received an experimental drug or used an experimental medical device within 28 days before allocation/randomization to IMP, or within a period less than 10 times the drug’s half-life,
    whichever is longer.
    4. Subject has a history or current condition of any one of the following:
    • Non-febrile seizure disorder.
    • Epilepsy.
    • Serotonin syndrome.
    • Traumatic or hypoxic brain injury, brain contusion, stroke, transient ischemic attack, intracranial hematoma, post-traumatic amnesia, brain neoplasm, or episode(s) of unconsciousness of more than 24 hours.
    5. Subject has a history or current condition of any one of the following:
    • Moderate to severe renal or hepatic impairment.
    • Abnormal pulmonary function or clinically relevant respiratory disease (e.g., acute or severe bronchial asthma, hypercapnia).
    6. Subject has a concomitant disease or disorder (e.g., endocrine, metabolic, neurological, psychiatric, infection, febrile seizure, paralytic ileus) that in the opinion of the investigator may affect or compromise subject safety during the trial participation.
    7. Subject has history of suicidal ideation or behavior.
    8. Subject is obese in the investigator´s judgement. Obesity can be determined based on appropriate BMI charts or tablets; e.g., a BMI above the 97th percentile for children based on the World Health Organization growth charts.
    9. Subject has a clinically relevant history of hypersensitivity, allergy, or contraindication to the supplemental opioid analgesic medication or tapentadol, or the excipients, or naloxone.
    10. Subject is not able to understand and comply with the protocol as appropriate for the age of the subject or subject is cognitively impaired in the investigator’s judgment such that they cannot comply with the protocol.
    11. Subject has a history of alcohol and/or substance abuse in the investigator’s judgment based on subject’s history and physical examination.
    12. Subject is taking prohibited concomitant medication.
    13. Subject has received a long-acting opioid for the treatment of pain following surgery within 6 hours of allocation/randomization to IMP.
    14. Subject has clinically relevant (in the investigator’s judgment) abnormal values for clinical chemistry or hematology (local laboratory sample taken after surgery).
    A subject is excluded if the:
    • Aspartate transaminase or alanine transaminase is >3-times upper limit of normal.
    • Total bilirubin is >2-times upper limit of normal (except if the cause is due to Gilbert’s syndrome).
    • Glomerular filtration rate <60 mL/min (calculated according to Schwartz et al. 1984).
    15. Subject has:
    • Clinically relevant abnormal ECG.
    • Signs of pre-excitation syndrome.
    • Brugada’s syndrome.
    • QT or QTc interval >470 ms for children aged 6 years to less than 18 years old.
    • QT or QTc interval >460 ms for children aged from birth to less than 6 years old.
    16. Peri- or post-operative analgesia supplied by a continuous regional technique (e.g. nerve block, wound infiltration catether) or subject controlled epidural analgesia that was terminated less than 6 hours before allocation/randomization to IMP.
    17. Subject has post-operative clinically unstable systolic and diastolic blood pressure, heart rate, respiratory depression, or clinically unstable upper or lower airway conditions (in the investigator’s
    judgment), or a saturation of peripheral oxygen (SpO2) <92% at the time of randomization (allocation/randomization to IMP).
    18. Female subject is breast-feeding a child.
    19. Subject requires continuous positive airway pressure or mechanical ventilation, at the time of allocation to IMP.
    20. The mother of a newborn subject or the breastfeeding mother of a subject was administered a prohibited medication.
    E.5 End points
    E.5.1Primary end point(s)
    The total amount of supplemental opioid analgesic medication (morphine equivalents in mg/kg body weight) used after first IMP intake.
    E.5.1.1Timepoint(s) of evaluation of this end point
    EU: 24 hours
    US: 12 hours
    E.5.2Secondary end point(s)
    The total amount of supplemental opioid analgesic medication received assessed in 12 hour intervals from 24 hours to 96 hours after the first dose of IMP.
    Palatability and acceptability of the IMP.
    Changes from baseline in pain intensity.
    Clinician Global Impression of Change.
    Patient Global Impression of Change.
    Time to first and time to second NCA/PCA after first dose of IMP.
    Time to first dose of IMP until IMP treatment discontinuation due to lack of efficacy.
    Safety
    • Percentage of subjects with TEAEs.
    • Percentages of subjects who develop abnormal:
    − Vital signs.
    − Laboratory parameters.
    − 12-lead ECG parameters.
    • Changes from baseline in vital signs parameters.
    • Changes from baseline in safety laboratory parameters.
    • Changes from baseline in 12-lead ECG parameters.
    • Percentage of subjects discontinuing the trial due to TEAEs and drug-related adverse events.
    • Suicidal ideation/behavior in subjects aged 6 years or older using the C-SSRS scores before IMP and at the end of the trial.
    • Sedation scores.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy endpoints:
    12 hours
    24 hours
    up to 96 hours
    Safety endpoints:
    up to Day 14
    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 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) Yes
    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 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) 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA53
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Bulgaria
    Croatia
    Czech Republic
    France
    Germany
    Hungary
    Poland
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 years
    E.8.9.1In the Member State concerned months5
    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 months6
    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 Yes
    F.1.1Number of subjects for this age range: 168
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 3
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 6
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 100
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 59
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 Yes
    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 of certain young age (determined by local laws) not capable of signing the informed consent form. In this situation the child will sign an assent form and his/her parent(s) or legal guardian(s) will sign an informed consent form.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 84
    F.4.2.2In the whole clinical trial 168
    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)
    Children and Adolscents will be treated after their last intake of IMP as per 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 Decision2015-12-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-14
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