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    Summary
    EudraCT Number:2005-003146-33
    Sponsor's Protocol Code Number:A6281265
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-11-29
    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 ConcernedSweden - MPA
    A.2EudraCT number2005-003146-33
    A.3Full title of the trial
    INDIVIDUALIZED DOSE OF GENOTROPIN® (SOMATROPIN) TO SHORT PREPUBERTAL CHILDREN BORN SMALL FOR GESTATIONAL AGE (SGA): COMPARISON WITH FIXED DOSE TREATMENT IN EVALUATION OF GROWTH AND SAFETY IN AN OPEN, PROSPECTIVE, RANDOMIZED MULTI-CENTER TRIAL (IDSGA)
    A.3.2Name or abbreviated title of the trial where available
    IDSGA
    A.4.1Sponsor's protocol code numberA6281265
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer AB
    B.1.3.4CountrySweden
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Genotropin 5 mg and 12 mg Genotropin MiniQuick 0.2-2.0mg
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameGenotropin
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant human growth hormone
    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
    TO SHORT PREPUBERTAL CHILDREN BORN SMALL FOR GESTATIONAL AGE
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Information not present in EudraCT
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate if an individualized dose is superior to the fixed dose in height catch-up expressed as DIFF SDS after 36 months of treatment.
    E.2.2Secondary objectives of the trial
    To evaluate
    - if an individualized dose of somatropin is as safe as the approved fixed standard dose with regard to carbohydrate metabolism, expressed as an abnormal oral glucose tolerance test (OGTT), after 36 months of treatment.
    - if an individualized dose of somatropin is as safe as the approved fixed standard dose with regard to insulin levels.
    - if an individualized dose is superior to the fixed dose in height catch-up expressed as DIFF SDS after 12 and 24 months of treatment.
    - the safety of an individualized dose as compared to a fixed standard dose with regard to lipid metabolism, body composition, standard laboratory tests, blood pressure and the occurrence of adverse events.
    - the difference between individualized and fixed dosing regimens with regard to change in height.
    - if there is a difference in the risk/benefit balance for increased risk of abnormal oral glucose tolerance test (OGTT) vs. improved height catch-up between the two treatment regimens.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Confirmed diagnosis of SGA: Gestational age known and ³30 weeks and birth weight and/or length < -2.0 SDS according to gestational age.
    - Chronological age at start of somatropin treatment: boys 2.0-9.0 years, girls 2.0-7.0 years of age.
    - Known parental heights, preferably measured but estimates will be accepted.
    - Height at screening below –2.5 SDS, with the appropriate Swedish population based reference Karlberg 2002.
    - GH evaluation (at least 12 hour night profile), not older than 3 years.
    - Signed written informed consent obtained from both parents/legal guardians of the child, and assent from the child as appropriate.
    E.4Principal exclusion criteria
    - Complicating disease, other than correctly treated hypothyroidism, such as celiac disease, neurological disease, hepatic disease, heart or renal failure, dyschondroplacias. Definition of complicating disease as judged by the Investigator.
    Past or ongoing malignant disease.
    - Diabetes mellitus Type I, Type II, or OGTT results abnormal at baseline
    - Concomitant syndromes (i.e. Turner syndrome verified by chromosomal analysis in girls and other syndromes such as bird headed syndrome, Noonan syndrome verified by photo at screening) other than Silver-Russell’s syndrome.
    - No height catch-up defined as 0 or negative difference between two repeated (first and second) height SDS measurements. Measurements must be performed within 5 and 7 months using the appropriate Swedish population based reference Karlberg 2002. Note; the subject must be at least 2,0 years old at the first measurement
    - Prior treatment with GH.
    - Unwillingness to participate in the trial, unable and/or unlikely to comprehend and/or follow the protocol or expected non-compliance
    - Participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry into the study.
    - Chronic oral glucocorticoid treatment, inhalation steroids (i.e. budesonid > 400 ug or fluticason >200ug)and treatment with hormones other than levothyroxin.
    - MHP SDS – Height SDS > - 1 SDS screening.
    - Pubertal signs: girls = Tanner breast stage >B1; boys: Prader testicular volume ³3 mL.
    - Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results, and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
    E.5 End points
    E.5.1Primary end point(s)
    - Change from baseline to 36 months in the DIFF SDS (MPH SDS-Height SDS )
    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 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 Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    fixed dose vs individual dose of Genotropin
    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 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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    Treatment duration is 36 months and visit 13, month 36, a final visit is performed.
    A subject may withdraw from the trial at any time at their own request, or they may be withdrawn at any time at the discretion of the investigator or sponsor for safety, behavioral, or administrative reasons. Every effort should be made to at least follow up on growth assessments on annual visits and assessments according to Visit 13/Final Visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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.1.1.6Adolescents (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 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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state111
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 111
    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)
    After trial completion the subjects will be treated according to the established routines at the site.
    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 Decision2007-01-29
    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 StatusPrematurely Ended
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