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Clinical trials for somatropin (Genotropin treatment)

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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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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    36 result(s) found for: somatropin (Genotropin treatment). Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2014-004173-16 Sponsor Protocol Number: A6281291 Start Date*: 2015-04-02
    Sponsor Name:Pfizer, Inc.
    Full Title: A Multicenter, Open-Label, Single Arm Study Assessing Dyad (Subject And Caregiver) Perception Of Convenience And Preference Of The Newly Developed Mark VII Pen
    Medical condition: Idiopathic Short Stature (ISS)
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2009-017354-12 Sponsor Protocol Number: A6281297 Start Date*: 2010-10-11
    Sponsor Name:Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK
    Full Title: A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN M...
    Medical condition: Subjects with Growth Hormone Deficiency
    Disease: Version SOC Term Classification Code Term Level
    12.1 10056438 Growth hormone deficiency LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) CZ (Completed) SK (Completed) DE (Completed) GB (Completed) NL (Ongoing)
    Trial results: View results
    EudraCT Number: 2018-000918-38 Sponsor Protocol Number: C0311002 Start Date*: 2019-05-16
    Sponsor Name:Pfizer Inc.
    Full Title: A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROP...
    Medical condition: Growth Hormone Deficiency in Children
    Disease: Version SOC Term Classification Code Term Level
    20.0 10014698 - Endocrine disorders 10056438 Growth hormone deficiency PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) SK (Completed) CZ (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2005-003146-33 Sponsor Protocol Number: A6281265 Start Date*: Information not available in EudraCT
    Sponsor Name:Pfizer AB
    Full Title: 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 OPE...
    Medical condition: TO SHORT PREPUBERTAL CHILDREN BORN SMALL FOR GESTATIONAL AGE
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: SE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2004-005223-18 Sponsor Protocol Number: NRA6280030 Start Date*: 2005-05-12
    Sponsor Name:Childrens´ Hospital Erlangen
    Full Title: Evaluation of growth response in short children suffering from a disease with growth retardation and treated with Somatropin: A prospective, longitudinal non-randomised, open, phase II study
    Medical condition: Genotropin®) is approved for treatment of short statured children in specific indications. A benefit can also be achieved in other pathological conditions that lead to growth retardation. Because ...
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-004172-32 Sponsor Protocol Number: A6281280 Start Date*: 2015-04-01
    Sponsor Name:Pfixer Inc
    Full Title: A Four-Year Open-Label Multi-Center Randomized Two-Arm Study of Genotropin in Idiopathic Short Stature Subjects: Comparing an Individualized, Target-Driven Treatment Regimen to Standard Dosing of G...
    Medical condition: Idiopathic short stature (ISS)
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2024-000101-32 Sponsor Protocol Number: A6281323 Start Date*: 2024-09-19
    Sponsor Name:Pfizer, Inc.
    Full Title: A PHASE 3 MULTICENTER, OPEN LABEL, MULTI COHORT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SOMATROPIN IN JAPANESE PARTICIPANTS WITH PRADER-WILLI SYNDROME (PWS)
    Medical condition: Prader-Willi Syndrome
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-002736-13 Sponsor Protocol Number: TV1106-IMM-30022 Start Date*: 2015-08-19
    Sponsor Name:Teva Pharmaceutical Industries Ltd.
    Full Title: A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-de...
    Medical condition: Growth hormone deficiency
    Disease: Version SOC Term Classification Code Term Level
    19.0 10014698 - Endocrine disorders 10056438 Growth hormone deficiency PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) HU (Completed) SE (Prematurely Ended) IT (Prematurely Ended) AT (Completed) ES (Prematurely Ended) SI (Prematurely Ended) LT (Prematurely Ended) GR (Prematurely Ended) CZ (Prematurely Ended) PL (Prematurely Ended) SK (Prematurely Ended) HR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2004-004781-33 Sponsor Protocol Number: A6281273 Start Date*: 2005-07-13
    Sponsor Name:Pfizer Pharma GmbH
    Full Title: Somatropin Therapy for Short Children Born of Premature Gestation: A Controlled, Prospective Randomized, Multicenter Study with an Untreated Control Group
    Medical condition: Short children born of premature gestation
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-004552-21 Sponsor Protocol Number: GENASG-0021-007 Start Date*: 2016-05-10
    Sponsor Name:Pfizer Japan Inc.
    Full Title: Long-term study of PNU-180307 for short children born small for gestational age (SGA) without epiphyseal closure (extension of the study 307-MET-0021-002)
    Medical condition: Small for Gestational Age
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004868 10041093 Small for gestational age LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-003874-42 Sponsor Protocol Number: CP-4-006 Start Date*: 2017-09-04
    Sponsor Name:OPKO Biologics Ltd.
    Full Title: A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency
    Medical condition: Growth hormone deficiency in pre-pubertal children
    Disease: Version SOC Term Classification Code Term Level
    20.0 10014698 - Endocrine disorders 10056438 Growth hormone deficiency PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) BG (Completed) FR (Completed) PL (Completed) ES (Ongoing) GR (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-000831-34 Sponsor Protocol Number: GoforGH Start Date*: 2022-01-11
    Sponsor Name:Medical University of Vienna
    Full Title: InvestiGating the rOle of Growth Hormone in hepatic lipid metabolism in humans
    Medical condition: Healthy subjects
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-003949-32 Sponsor Protocol Number: A6281287 Start Date*: 2007-12-21
    Sponsor Name:Pfizer Ltd. Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK
    Full Title: A two-year multi-centre, randomized two arm study of Genotropin treatment in very young children born small for gestational age: Early Growth and Neurodevelopment (EGN)
    Medical condition: Short Stature children born small for Gestational Age (SGA)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10036585 - Pregnancy, puerperium and perinatal conditions 10041093 Small for gestational age LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) CZ (Completed) BE (Completed) ES (Completed) AT (Completed) GB (Completed) FR (Completed) IT (Completed) DE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2008-004849-28 Sponsor Protocol Number: FE 999905 CS07 Start Date*: 2009-07-09
    Sponsor Name:Ferring Pharmaceuticals A/S
    Full Title: A randomised, open-label, parallel-group, multi-centre trial comparing the efficacy and safety of 12 months treatment with one daily dose of ZOMACTON® to one daily dose of GENOTROPIN® in the treatm...
    Medical condition: Idiopathic growth hormone deficiency.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10056438 Growth hormone deficiency LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: View results
    EudraCT Number: 2004-004719-43 Sponsor Protocol Number: Start Date*: 2005-06-30
    Sponsor Name:University of Cambridge
    Full Title: The Effects of 6-Month Administration of a Low Growth Hormone Dose on Insulin Sensitivity, Postload Glucose Tolerance and Cardiovascular Disease Risk Markers in Subjects with Impaired Glucose Toler...
    Medical condition: Impaired Glucose Tolerance
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-000346-36 Sponsor Protocol Number: BPLG-004 Start Date*: Information not available in EudraCT
    Sponsor Name:BioPartners GmbH [...]
    1. BioPartners GmbH
    2. LG Life Science Ltd.
    Full Title: A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Dai...
    Medical condition: pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion
    Disease: Version SOC Term Classification Code Term Level
    10056438 LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: AT (Completed) FI (Prematurely Ended) SE (Prematurely Ended) SK (Completed) HU (Completed) CZ (Prematurely Ended) IT (Completed) DE (Completed) LT (Prematurely Ended) EE (Prematurely Ended) LV (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-000446-56 Sponsor Protocol Number: CRT076 Start Date*: 2016-03-07
    Sponsor Name:Cristália Produtos Químicos Farmacêuticos Ltda.
    Full Title: Clinical study to compare recombinant human growth hormone Cristalia (r-hGH Cristalia) versus Genotropin® in prepubertal children with growth deficiency due to deficiency of growth hormone.
    Medical condition: Growth deficiency due to growth hormone deficiency
    Disease: Version SOC Term Classification Code Term Level
    18.1 10014698 - Endocrine disorders 10056438 Growth hormone deficiency PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2013-004468-69 Sponsor Protocol Number: TV1106-IMM-20001 Start Date*: 2014-06-11
    Sponsor Name:Teva Pharmaceutical Industries, Ltd.
    Full Title: A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing 3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone (Genotropin®) Therapy in Treatment-Naive,...
    Medical condition: Growth hormone deficiency
    Disease: Version SOC Term Classification Code Term Level
    17.0 10014698 - Endocrine disorders 10056438 Growth hormone deficiency PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) CZ (Prematurely Ended) RO (Ongoing) GR (Prematurely Ended) BG (Prematurely Ended) ES (Prematurely Ended) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-004160-38 Sponsor Protocol Number: 93-8122-001 Start Date*: 2015-04-01
    Sponsor Name:KABI PHARMACIA S.A.
    Full Title: A 2 Year Multicenter Study of Genotropin Treatment of Short Prepubertal Children with Intra-Uterine Growth Retardation
    Medical condition: Growth Disorders, Intrauterine Growth Retardation
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-001145-11 Sponsor Protocol Number: TransCon_hGH_CT-301 Start Date*: 2018-02-12
    Sponsor Name:Ascendis Pharma Endocrinology Division A/S
    Full Title: A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard...
    Medical condition: Growth hormone deficiency (GHD) in prepubertal children
    Disease: Version SOC Term Classification Code Term Level
    20.0 10014698 - Endocrine disorders 10056438 Growth hormone deficiency PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) BG (Completed) PL (Completed) GR (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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