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Clinical trials for Lodotra

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   44335   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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    5 result(s) found for: Lodotra. Displaying page 1 of 1.
    EudraCT Number: 2007-007316-29 Sponsor Protocol Number: NP01-201 Start Date*: 2008-05-07
    Sponsor Name:Nitec Pharma AG
    Full Title: A New Modified-Release Tablet Formulation of Prednisone (Lodotra) in Patients with Nocturnal Asthma An open-label explorative study
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    10.1 10003553 LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-002353-57 Sponsor Protocol Number: LOD3501 Start Date*: 2013-02-25
    Sponsor Name:Mundipharma Research Limited
    Full Title: A randomised, multi-centre, double-blind, active-controlled, parallel group study to assess the efficacy and safety of modified release prednisone (Lodotra®) compared to immediate release prednison...
    Medical condition: polymyalgia rheumatica
    Disease: Version SOC Term Classification Code Term Level
    16.1 10028395 - Musculoskeletal and connective tissue disorders 10036099 Polymyalgia rheumatica PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) CZ (Prematurely Ended) GB (Prematurely Ended) HU (Prematurely Ended) ES (Completed) DK (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-003508-36 Sponsor Protocol Number: NP01-007 Start Date*: 2008-06-17
    Sponsor Name:Nitec Pharma AG
    Full Title: A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis
    Medical condition: Rheumatoid arthritis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039073 Rheumatoid arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) GB (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2011-005090-22 Sponsor Protocol Number: 001 Start Date*: 2012-02-28
    Sponsor Name:Southend Hospital
    Full Title: A study of efficacy and safety of delayed release prednisone in newly diagnosed cases of Giant Cell Arteritis
    Medical condition: Giant Cell Arteritis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10047065 - Vascular disorders 10018250 Giant cell arteritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2008-007315-32 Sponsor Protocol Number: ME/2008/3031 Start Date*: 2009-04-21
    Sponsor Name:University Hospitals Bristol NHS Foundation Trust
    Full Title: CIRCADIAN VARIATIONS IN CYTOKINES AND THE EFFECT OF TIMED RELEASE TABLET PREDNISONE IN POLYMYALGIA RHEUMATICA
    Medical condition: Polymyalgia Rheumatica
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036099 Polymyalgia rheumatica LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
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    Query did not match any studies.
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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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