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Clinical trials for Idiopathic short stature

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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • 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   44338   clinical trials with a EudraCT protocol, of which   7368   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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    10 result(s) found for: Idiopathic short stature. Displaying page 1 of 1.
    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: 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: 2007-003247-70 Sponsor Protocol Number: UZAPED1 Start Date*: 2007-10-29
    Sponsor Name:Belgian Study Group for Pediatric Endocrinology
    Full Title: Efficacy and safety of a 4 year combination therapy of growth hormone and gonadotropin- releasing hormone agonist in children with a short predicted height.
    Medical condition: predicted short stature
    Disease: Version SOC Term Classification Code Term Level
    9.1 10066333 Idiopathic short stature LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-005607-13 Sponsor Protocol Number: NN8640-4467 Start Date*: 2022-07-15
    Sponsor Name:NOVO NORDISK. S.P.A.
    Full Title: A study comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® as well as evaluating long-term safety of somapacitan in a basket study design in children with ...
    Medical condition: Short stature born small for gestational age Turner syndrome Noonan syndrome Idiopathic short stature
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10045181 Turner's syndrome PT
    20.0 10010331 - Congenital, familial and genetic disorders 10029748 Noonan syndrome PT
    23.0 100000004859 10066333 Idiopathic short stature LLT
    21.1 100000004868 10041093 Small for gestational age LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: IT (Trial now transitioned) SI (Trial now transitioned) IE (Completed) DE (Trial now transitioned) FI (Trial now transitioned) GR (Trial now transitioned) NL (Trial now transitioned) BE (Trial now transitioned) AT (Trial now transitioned) ES (Ongoing) PT (Trial now transitioned) FR (Trial now transitioned) BG (Trial now transitioned) PL (Trial now transitioned) LV (Trial now transitioned) HR (Trial now transitioned) LT (Trial now transitioned)
    Trial results: (No results available)
    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: 2010-019980-13 Sponsor Protocol Number: A-95-58035-017 Start Date*: 2012-05-14
    Sponsor Name:Ipsen Farmaceutica b.v.
    Full Title: Predictive value of baseline and stimulated serum IGF-I and IGFBP-3 during a dose-escalation IGF-I generation test with NutropinAq for the 1 year growth response to growth hormone (GH) therapy in s...
    Medical condition: Severe idiopathic short stature
    Disease: Version SOC Term Classification Code Term Level
    14.0 10028395 - Musculoskeletal and connective tissue disorders 10066333 Idiopathic short stature LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-002684-25 Sponsor Protocol Number: BSGPE2 Start Date*: 2012-08-06
    Sponsor Name:Antwerp University Hospital
    Full Title: Efficacy and safety of a 4 year pubertal therapy with growth hormone (somatropine Omnitrope) or an aromatase inhibitor (letrozole Femara) or the combination of both in boys with a short predicted h...
    Medical condition: boys with idiopathic short adult stature defined as a predicted adult height below or equal to 164.0 cm ( -2.5 SDS) without a known cause
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004859 10066333 Idiopathic short stature LLT
    Population Age: Adolescents, Under 18 Gender: Male
    Trial protocol: BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-004104-30 Sponsor Protocol Number: 307-MET-9002-0009 Start Date*: 2015-04-01
    Sponsor Name:Pharmacia & Upjohn S.A.
    Full Title: Treatment With Recombinant Human Growth Hormone (Genotonorm) in Children With Short Stature Secondary to a Long Term Corticoid Therapy. A Study of Efficacy and Safety
    Medical condition: Juvenile idiopathic arthritis (JIA) and nephrotic syndrome (NeS)
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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: 2011-000460-10 Sponsor Protocol Number: EMR200104_10 Start Date*: 2011-08-03
    Sponsor Name:Merck Serono SA
    Full Title: First year growth response associated genetic markers validation Phase IV open-label study in Growth Hormone Deficient and Turner Syndrome pre-pubertal children : the PREDICT Pharmacogenetics V...
    Medical condition: idiopathic growth hormone deficienty Turner Syndrome
    Disease: Version SOC Term Classification Code Term Level
    13.1 10014698 - Endocrine disorders 10056438 Growth hormone deficiency PT
    13.1 10010331 - Congenital, familial and genetic disorders 10045181 Turner's syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) CZ (Completed) IT (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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