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    The EU Clinical Trials Register currently displays   42312   clinical trials with a EudraCT protocol, of which   6968   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2008-003178-17
    Sponsor's Protocol Code Number:0869-148
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2011-07-01
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2008-003178-17
    A.3Full title of the trial
    A Multicenter, 2-Part Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Aprepitant in Pediatric Patients Undergoing Surgery.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Aprepitant in Pediatric Patients Undergoing Surgery
    A.4.1Sponsor's protocol code number0869-148
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/97/2008
    B. Sponsor Information
    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 nameAprepitant
    D.3.2Product code MK-0869
    D.3.4Pharmaceutical form Powder for oral suspension
    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 INNAprepitant
    D.3.9.1CAS number 170729-80-3
    D.3.9.2Current sponsor codeMK-0869
    D.3.9.3Other descriptive nameATC code: A04AD12
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 RoleComparator
    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 ZOFRAN Injection
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Operations UK Limited
    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 nameZOFRAN Injection
    D.3.2Product code ondansetron hydrochloride
    D.3.4Pharmaceutical form Solution for injection
    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 INNondansetron HCl dihydrate
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 placeboPowder for oral suspension
    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
    Prevention of Postoperative nausea and vomiting in pediatric patients.
    E.1.1.1Medical condition in easily understood language
    Prevention of Postoperative nausea and vomiting in pediatric patients.
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10036901
    E.1.2Term Prophylaxis against postoperative nausea and vomiting
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To estimate postoperative aprepitant plasma concentration profiles and pharmacokinetic parameters (AUC0-48, Cmax, Tmax, C24 hr, and C48 hr) obtained from infants 6 months to < 2 years of age and children 2 to < 6 years, 6 to < 12 years, and 12 to 17 years of age administered oral aprepitant preoperatively.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of the administered dose(s) of aprepitant in patients 6 months to 17 years of age.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients are 6 months to 17 years of age at the time of study entry
    2. Patient is scheduled to undergo surgery (such as but not limited to abdominal, pelvic, perineal, plastic surgery to repair physical deformity, or orthopedic surgery) requiring a 48 hour hospital stay after the end of surgery.
    3. Patient weighs ≥ 6 kg and has an American Society of anesthesia (ASA) physical status of I-III.
    4. Patient is scheduled to receive postoperative opioids (e.g., morphine, or fentanyl) by oral, rectal, intramuscular (IM) or IV administration, or patient controlled analgesia (PCA).
    5. Patient is scheduled to receive general anesthesia with the following general anesthetic regimen:
    • Induction with any inhaled anesthetic agent
    • Opioids (e.g., fentanyl, morphine, or hydromorphone
    6. Patient has an existing vascular catheter (peripheral or central) prior to receiving aprepitant
    E.4Principal exclusion criteria
    1. Patient is undergoing surgery for a life threatening condition.
    2. Placement of nasogastric or oral gastric tube intra- or postoperatively. (Patients should be excluded if a nasogastric or oral gastric tube is routinely used for the type of surgery to be performed.
    3. Patient is scheduled to receive propofol for maintenance of anesthesia. (Note: propofol is permitted for induction of anesthesia in addition to an inhaled anesthetic agent.)
    4. Patient is taking, or has taken within 7 days of surgery the following cytochrome:
    P450 3A4(CYP3A4) substrates:Terfenadine, Cisapride, Astemizole, Pimozide
    5. Patient is taking, or has taken within 7 days of surgery the following CYP3A4 inhibitors:
    • Clarithromycin, erythromycin, ketoconazole, itraconazole ,fluconazole or telithromycin
    6. Patient is taking, or has taken within 30 days of surgery the following CYP3A4 inducers:
    • Phenytoin or carbamazepine, barbiturates, rifampicin or rifabutin, St. John’s Wort
    7. Patient is allergic to scheduled preoperative tranquilizer, operative anesthetics,
    postoperative analgesia, ondansetron or any 5HT3 antagonist, or aprepitant.
    8. Patient is expected to receive neuroaxial anesthesia such as epidural, spinal or caudal anesthesia. (Patients should be excluded if neuroaxial anesthesia is routinely used for the type of surgery to be performed.
    9. Patient has ever participated in a study with aprepitant or fosaprepitant, is currently participating in a study with another NK-1 antagonist, or has taken a non-approved (investigational) drug within the last 4 weeks.

    E.5 End points
    E.5.1Primary end point(s)
    Pharmacokinetic Endpoint (Part I)
    Pharmacokinetic (PK) profile (AUC0-48, Cmax, Tmax, C24 hr, C48 hr) of the administered dose of aprepitant will be determined for patients aged 6 months to 17 years.

    Safety Endpoints:.
    Any, drug-related, serious, and serious drug-related adverse experience(s) during study therapy plus 14 days post therapy or drug-related adverse experience(s) leading to discontinuation of aprepitant therapy will be analyzed to assess tolerability.. Safety data will be assessed separately for each Part.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of Trial
    E.5.2Secondary end point(s)
    N/A
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    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 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) Yes
    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) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3.1Comparator description
    Zofran
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Brazil
    Mexico
    Russian Federation
    Turkey
    United States
    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 Patient Last Visit (LPLV)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    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: 92
    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: 22
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 46
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 24
    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 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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 92
    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)
    N/A
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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