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Clinical trials for chronocort

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   44339   clinical trials with a EudraCT protocol, of which   7369   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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    5 result(s) found for: chronocort. Displaying page 1 of 1.
    EudraCT Number: 2021-004467-26 Sponsor Protocol Number: DIUR015 Start Date*: 2022-02-08
    Sponsor Name:Neurocrine UK Limited
    Full Title: A Phase 3 Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Chronocort in the Treatment of Participants Aged 16 Years and Over with Congenital Adrenal Hyperplasia
    Medical condition: Congenital Adrenal Hyperplasia due to 21-hydroxylase deficiency
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-003668-29 Sponsor Protocol Number: DIUR-014 Start Date*: 2022-02-04
    Sponsor Name:Diurnal Limited
    Full Title: A Randomized, Double-Blind, Active-Controlled, Phase 3 Study of Chronocort Compared with Immediate-Release Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over with Congenital ...
    Medical condition: Congenital Adrenal Hyperplasia due to 21-hydroxylase deficiency
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2015-005448-32 Sponsor Protocol Number: DIUR-006 Start Date*: 2016-07-20
    Sponsor Name:Diurnal Ltd
    Full Title: A Phase III extension study of efficacy, safety and tolerability of Chronocort® in the treatment of congenital adrenal hyperplasia (CAH)
    Medical condition: Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, ...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10010323 Congenital adrenal hyperplasia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) SE (Completed) DE (Completed) DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-000144-21 Sponsor Protocol Number: DIUR-016-AI Start Date*: 2022-01-14
    Sponsor Name:Diurnal Limited
    Full Title: A Double-Blind, Double-Dummy, Two-Way Cross-Over, Randomised, Phase II Study of Efficacy, Safety and Tolerability of Modified-Release Hydrocortisones: Chronocort® Versus Plenadren®, in Adrenal Insu...
    Medical condition: Adrenal Insufficiency (AI)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10014698 - Endocrine disorders 10052381 Primary adrenal insufficiency PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-000711-40 Sponsor Protocol Number: DIUR-005 Start Date*: 2015-11-19
    Sponsor Name:Diurnal Ltd
    Full Title: A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia.
    Medical condition: Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, ...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10010323 Congenital adrenal hyperplasia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) SE (Completed) NL (Completed) DK (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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