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Clinical trials for Somatropin

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    88 result(s) found for: Somatropin. Displaying page 1 of 5.
    1  2  3  4  5  Next»
    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: 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: 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: 2014-000563-41 Sponsor Protocol Number: IMIMFTCL/GH/4 Start Date*: 2014-08-08
    Sponsor Name:Consorci Mar Parc de Salut de Barcelona (Parc de Salut Mar)
    Full Title: Recombinant hGH Biomarkers Discovery
    Medical condition: Healthy volunteers. There is not intended indication.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-001750-25 Sponsor Protocol Number: B9R-FP-GDGI Start Date*: 2007-03-22
    Sponsor Name:LILLY FRANCE
    Full Title: Efficacy and Safety of Somatropin in Combination with Leuprorelin Compared to Somatropin Alone and to an Untreated Control Group in Pubertal Children with Idiopathic Short Stature
    Medical condition: Children with Idiopathic Short Stature (ISS) at puberty onset.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10040600 Short stature LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed)
    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: 2018-000750-22 Sponsor Protocol Number: GHLIQUID-4020 Start Date*: 2018-04-12
    Sponsor Name:Novo Nordisk A/S
    Full Title: A trial investigating the long-term efficacy and safety of two doses of NN-220 (somatropin [genetical recombination]) in short stature due to Noonan syndrome
    Medical condition: Noonan Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10029748 Noonan syndrome PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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: 2012-004975-37 Sponsor Protocol Number: TV1106-GHD-201 Start Date*: 2013-01-21
    Sponsor Name:Teva Pharmaceutical Industries Ltd.
    Full Title: A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with G...
    Medical condition: Growth hormone deficiency
    Disease: Version SOC Term Classification Code Term Level
    17.1 10014698 - Endocrine disorders 10056438 Growth hormone deficiency PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) SK (Completed) GR (Completed) SI (Completed) DE (Completed) SE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-002613-30 Sponsor Protocol Number: GH-3899 Start Date*: 2016-04-25
    Sponsor Name:Novo Nordisk A/S
    Full Title: A 12-month, open-labelled, randomised, parallel-group, multi-centre, interventional trial to evaluate the efficacy and safety of recombinant human growth hormone (hGH) (Norditropin® Nordilet®) ther...
    Medical condition: Idiopathic short stature
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004859 10066333 Idiopathic short stature LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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: 2005-001539-31 Sponsor Protocol Number: FE999905 CS002 Start Date*: 2005-09-16
    Sponsor Name:Ferring Pharmaceuticals A/S
    Full Title: An Open-label, Multi-centre, Phase III Study of Local Tolerability of Zomacton 10 mg (Recombinant Somatropin) administered by ZomaJet Vision X
    Medical condition: Zomacton is indicated for the long term treatment of children who have growth failure due to inadequate secretion of growth hormone and for the long-term treatment of growth retardation due to Turn...
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    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: 2006-004702-56 Sponsor Protocol Number: NN1630-1453 Start Date*: 2007-08-07
    Sponsor Name:Novo Nordisk A/S
    Full Title: Outcome Trial Evaluating the Efficacy and Safety of Norditropin® in Adult Patients on Chronic Haemodialysis A Randomised, Double-blind, Parallel group, placebo controlled, Multi-centre trial
    Medical condition: Adult Patients in Chronic Dialysis (APCD)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10066623 Chronic haemodialysis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended) FR (Completed) ES (Completed) DE (Prematurely Ended) IT (Prematurely Ended) PT (Prematurely Ended) HU (Completed) SE (Prematurely Ended) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-017387-16 Sponsor Protocol Number: GH-3826 Start Date*: 2010-08-31
    Sponsor Name:Novo Nordisk Pharmaceutique S.A.S
    Full Title: To assess ease of use, acceptability and preference of Norditropin NordiFlex® in subjects on prescribed growth hormone therapy
    Medical condition: children aged 6 years or more receiving growth hormone therapy for the following approved indications (according to Norditropine SPC) -GHD -Turner Syndrome -small for gestational age -chronic rena...
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2020-000929-42 Sponsor Protocol Number: TCH-306 Start Date*: 2021-06-09
    Sponsor Name:Ascendis Pharma Endocrinology Division A/S
    Full Title: foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin ...
    Medical condition: Adult Growth Hormone Deficiency (AGHD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10014698 - Endocrine disorders 10056438 Growth hormone deficiency PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) SK (Completed) FR (Completed) DK (Prematurely Ended) BG (Completed) ES (Ongoing) NL (Completed) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-000231-27 Sponsor Protocol Number: NN8640-4263 Start Date*: 2019-04-23
    Sponsor Name:Novo Nordisk A/S
    Full Title: A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency
    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, Under 18 Gender: Male, Female
    Trial protocol: DE (Ongoing) FR (Trial now transitioned) DK (Completed) AT (Ongoing) SI (Trial now transitioned) GB (GB - no longer in EU/EEA) NO (Ongoing) IE (Completed) EE (Completed) LV (Trial now transitioned) PL (Trial now transitioned) HU (Completed) ES (Ongoing) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-000914-47 Sponsor Protocol Number: GHLIQUID-1517 Start Date*: 2017-05-23
    Sponsor Name:Novo Nordisk A/S
    Full Title: A long-term, multi-centre, randomised, controlled, double-blind, parallel-group trial, investigating the efficacy and safety of two doses of NN-220 in subjects with short stature born small for ges...
    Medical condition: Foetal growth problem Small for Gestational Age 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, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-000042-37 Sponsor Protocol Number: GHNOO-1658 Start Date*: 2005-07-11
    Sponsor Name:Novo Nordisk A/S
    Full Title: Norditropin Treatment in Subjects with Noonan Syndrome. Effects on Linear Growth and Final Height - Data Collection and Follow-up Visit
    Medical condition: Noonan syndrome associated short stature
    Disease: Version SOC Term Classification Code Term Level
    7.1 10029748 PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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