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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2010-022971-79
    Sponsor's Protocol Code Number:PALO-10-14
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-05-17
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2010-022971-79
    A.3Full title of the trial
    A Multicenter, Double-blind, Double-dummy, Randomized, Parallel Group, Stratified Study to Evaluate the Efficacy and Safety of a Single IV Dose of Palonosetron Compared to a Single IV Dose of Ondansetron to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Not applicable
    A.4.1Sponsor's protocol code numberPALO-10-14
    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 SponsorHelsinn Healthcare SA
    B.1.3.4CountrySwitzerland
    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 supportHelsinn Healthcare SA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPSI Pharma Support Poland Sp. z o.o.
    B.5.2Functional name of contact pointNot Applicable
    B.5.3 Address:
    B.5.3.1Street Address1 Sierpnia 6A
    B.5.3.2Town/ cityWarsaw
    B.5.3.3Post code02-134
    B.5.3.4CountryPoland
    B.5.4Telephone number+48 22 210 02 00
    B.5.5Fax number+48 22 210 02 20
    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 Aloxi
    D.2.1.1.2Name of the Marketing Authorisation holderHelsinn Birex Pharmaceuticals Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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
    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 INNPALONOSETRON
    D.3.9.1CAS number 135729-62-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.05
    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
    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.3.4Pharmaceutical 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
    D.3.9.1CAS number 99614-02-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.0
    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
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postoperative nausea and vomiting (PONV)
    E.1.1.1Medical condition in easily understood language
    Not applicable
    E.1.1.2Therapeutic area Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10036238
    E.1.2Term Postoperative vomiting
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10036285
    E.1.2Term Postoperative nausea
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the efficacy of a single palonosetron IV dose compared to a single ondansetron IV dose in the prevention of postoperative nausea and vomiting through 24 hours after surgery in children aged from 1 month up to less than 17 years undergoing elective surgical procedures requiring general intravenous anesthesia.
    E.2.2Secondary objectives of the trial
    The secondary objective is to evaluate the safety and tolerability of IV palonosetron in pediatric patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Written informed consent to be signed by parent(s) of the pediatric patient in compliance with the local law regulations. In addition signed children’s assent form according to local requirements.
    2.Male or female patient aged from 1 month to less than 17 years.
    3.In-patient or out-patient scheduled to undergo one of the following procedures:
    •ear, nose and throat surgery (e.g., tonsillectomy, adenoidectomy, myringotomy),
    •eye surgery (e.g. strabismus, vitreoretinal, cataract surgery),
    •urological surgery (e.g. orchidopexy, varicocoele)
    •plastic reconstructive surgery (e.g. cleft lip/cleft palate, burn procedures involving the scalp),
    •hernia repair,
    •orthopedic surgery (e.g. foot and ankle deformities, arthroscopic surgeries, ACL surgery)
    •cardiac surgery,
    •neurosurgery.
    4.Patient is scheduled to undergo surgery requiring general intravenous anesthesia.
    5.Patient scheduled to receive nitrous oxide during the maintenance phase of anesthesia.
    6.Patient weight at least 3.2 kg.
    7.ASA physical status I, II or III.
    8.Fertile patients (male or female) must use reliable contraceptive measures (such measures, for patients and sexual partners, include: implants, injectables, combined oral contraceptives, intrauterine devices, double-barrier methods, vasectomized/sterilized partner or sexual abstinence).
    9.Female patients who have attained menarche must have a negative pregnancy test at the screening visit (Visit 1) and at study treatment visit (Visit 2). The patient and her parent(s) must be counseled on the importance of not becoming pregnant before or during the study.
    10.For patients with known hepatic impairment: in the investigator’s opinion the impairment does not jeopardize patient’s safety during the study.
    11.For patients with known renal impairment: in the investigator’s opinion the impairment does not jeopardize patient’s safety during the study.
    E.4Principal exclusion criteria
    1. The patient and/or parents/caregivers are expected by the Investigator to be non-compliant with the study procedures.
    2. Lactating females.
    3. Patient aged ≤6 years who received any investigational drug within 90 days prior to Day 1, or patient aged >6 who received any investigational drug within 30 days prior to Day 1 or is expected to receive investigational drugs prior to study completion.
    4. Patient having participated in any previous trial with palonosetron.
    5. History of allergy to any components or any other contraindications to the use of any 5-HT3 receptor antagonists.
    6. Patient to undergo emergency surgery.
    7. Patient scheduled to receive regional anesthesia (lumbar, epidural, spinal) alone or in conjunction with general intravenous anesthesia.
    8. Patient scheduled to receive laryngeal mask anesthesia.
    9. Patient scheduled to receive propofol during the maintenance phase of anesthesia.
    10. Patient scheduled to receive intragastric tube in situ postoperatively.
    11. Patient suffering from any concomitant disease uncontrolled by therapy, which, at the judgment of the Investigator, could compromise the outcome of surgery.
    12. Patient with history of gastro-esophageal reflux (except for patients up to 12 months).
    13. Patient with ongoing vomiting from any organic cause.
    14. Patient having experienced any vomiting, retching, or nausea within 24 hours prior to the administration of the study drug.
    15. Use of any of the following drug with potential anti-emetic effect within 48h prior to surgery (Appendix D):
    • 5-HT3 antagonists (e.g., ondansetron, granisetron, dolasetron);
    • Phenothiazines (e.g., perphenazine, prochlorperazine, promethazine, fluphenazine, chlorpromazine, thiethylperazine);
    • Butyrophenones (e.g., droperidol, haloperidol);
    • Benzamides (e.g., metoclopramide, alizapride);
    • Systemic corticosteroids (e.g., dexamethasone, prednisone, methylprednisolone; except inhaled steroids for respiratory disorders and topical steroids for skin disease);
    • Dimenhydrinate; hydroxyzine; domperidone; lorazepam; cyclizine; cannabinoids; scopolamine; trimetobenzamide HCl; meclizine hydrochloride; pseudoephedrine HCl;
    • Over the Counter (OTC) antiemetics, OTC cold or OTC allergy medications;
    • Herbal preparations containing ephedra or ginger.

    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint: Proportion of patients showing Complete Response (CR; defined as no vomiting, no retching, and no use of antiemetic rescue medication)
    E.5.1.1Timepoint(s) of evaluation of this end point
    during the first 24 hours, starting as soon as the patient wakes up and is able to show any active reaction postoperatively (e.g., respond to commands, speak, cry, lift head, open eyes or squeeze hand)
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints (0-24 hours) are:
    • Proportion of patients with no vomiting
    • Proportion of patients without emetic episodes
    • Proportion of patients without antiemetic rescue medication
    • Proportion of patients without nausea (patients aged ≥ 6 years)
    • Time to first vomiting
    • Time to first emetic episode
    • Time to first administration of rescue medication.
    • Time to treatment failure (time to first emetic episode or time to first administration of rescue medication, whichever occur first)
    E.5.2.1Timepoint(s) of evaluation of this end point
    during the first 24 hours, starting as soon as the patient wakes up and is able to show any active reaction postoperatively (e.g., respond to commands, speak, cry, lift head, open eyes or squeeze hand)
    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) 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 Yes
    E.8.1.7.1Other trial design description
    double dummy
    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.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Argentina
    Russian Federation
    Ukraine
    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
    The planned duration of the study is a maximum of 32 days. Subjects with ongoing AEs at the follow-up visit and subjects who have an SAE within 30 days after study drug administration will be followed as necessary until the AE or SAE resolves or stabilizes.
    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 days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    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: 660
    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.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    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
    Pediatric Patients
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state115
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 310
    F.4.2.2In the whole clinical trial 660
    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)
    Not applicable
    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 Decision2011-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-03-27
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