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    Summary
    EudraCT Number:2004-002991-40
    Sponsor's Protocol Code Number:A6281269
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-04-01
    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 number2004-002991-40
    A.3Full title of the trial
    Evolution of Growth Rate in Children Suffering From a
    Disease Associated With Growth Retardation and Treated by
    Genotonorm. A Pilot Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Growth Retardation in Children With Special Pathological Conditions or Disease
    A.4.1Sponsor's protocol code numberA6281269
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00163215
    A.5.4Other Identifiers
    Name:AliasNumber:93-8122-001; CTN 93-8122-001
    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 SponsorPfizer Inc
    B.1.3.4CountryUnited States
    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 supportPfizer Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointPfizer Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42 Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post code10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number1212733-2323
    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 nameGenrotropin
    D.3.4Pharmaceutical form Powder and solution for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSomatropin
    D.3.9.3Other descriptive nameSOMATROPIN
    D.3.9.4EV Substance CodeSUB10584MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5.3 to 12
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Growth Disorders, Growth Retardation
    E.1.1.1Medical condition in easily understood language
    Growth failure seen in children
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To show an increase in annual growth rate 3 years after Visit 2. anual growth rate in standard deviation (SD) after 3 years will be compared to growth rate before the start of growth hormone (GH) treatment.
    E.2.2Secondary objectives of the trial
    To estimate the evolution of height under GH treatment after 1, 2 and 3 years
    To estimate the growth rate 1 and 2 years after inclusion in the study
    To confirm the good clinical and biological safety of GH treatment in such children
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. For GH treatment issue bone age should be less than (<) 13 years for a boy and < 11 years for a girl.2. Naïve child: with measured height should be < 2.5 SD for chronological age (CA).
    Child currently treated by GH should have annual growth rate greater than equal to (>=) +1 SD and measured height <-2.5 SD for CA at the time GH was started.
    3. Documented disease or pathological conditions known to be associated with growth
    retardation and/or an adult height < -2 SD.
    4. Children with the same pathological condition or disease.
    5. Genotonorm treatment can be initiated by a physician according to the French SCP. that is to say a physician working in a hospital pediatric department or in a hospital endocrinology and metabolic disease department and, who is a pediatrician and/or a pediatric endocrinologist
    6. The child benefits of the French social security cover.
    E.4Principal exclusion criteria
    1. Idiopathic short stature.
    2. Pathological condition or disease for which GH treatment is already approved in France.
    3. Glucose intolerance on an oral glucose tolerance test dated less than 3 months or diabetes mellitus.
    4. Syndrome known to be associated with an increased risk of cancer example. family history of adenomatous polyposis.
    5. Participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study.
    6. Unable and/or unlikely to comprehend and/or follow GH treatment and/or the
    protocol.
    7. A previous history of intolerance or hypersensitivity to the study drug, or to drugs with similar chemical structures.
    8. Subjects who are known or are suspected allergic to the preservative metacresol.
    9. Pharmacological treatment with steroids for 1 year or more.
    E.5 End points
    E.5.1Primary end point(s)
    1) Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Intent-to-Treat (ITT) Population
    2) Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Per-Protocol (PP) Population
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) Baseline, Month 36
    2) Baseline, Month 36
    E.5.2Secondary end point(s)
    1) Change From Baseline in Annual Growth Rate at Month 12, Month 24 and Month 36 in ITT Population
    2) Change From Baseline in Annual Growth Rate at Month 12, Month 24, Month 36 in PP Population
    3) Height
    4) Change From Baseline in Height at Month 12, Month 24 and Month 36
    5) Mean Height Standard Deviation Score (SDS) for Chronological Age (CA)
    6) Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, Month 24 and Month 36
    7) Mean Height Standard Deviation Score (SDS) for Bone Age (BA)
    8) Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, Month 24 and Month 36
    9) Baseline, Month 12, Month 24, Month 36
    10) Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12 and Month 24 in ITT Population
    11) Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12 and Month 24 in PP Population
    12) Mean Growth Rate Standard Deviation Score (SDS) for Bone Age (BA)
    13) Body Mass Index (BMI)
    14) Change From Baseline in Body Mass Index (BMI) at Month 12, Month 24 and Month 36
    15) Change From Baseline in Bone Age (BA) at Month 12, Month 24 and Month 36
    16) Ratio of Bone Age (BA) to Chronological Age (CA)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, Month 12, Month 24 and Month 36
    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 No
    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 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 Yes
    E.8.1.7.1Other trial design description
    Longitudinal
    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 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
    France
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days19
    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: 46
    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: 25
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 21
    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
    Subject less than 18 years
    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 46
    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)
    None
    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: France
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