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Clinical trials for Retapamulin

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   44364   clinical trials with a EudraCT protocol, of which   7388   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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    8 result(s) found for: Retapamulin. Displaying page 1 of 1.
    EudraCT Number: 2015-004903-22 Sponsor Protocol Number: TOC110977 Start Date*: 2016-12-12
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A randomized, double-blind, multicenter, superiority Phase III study to assess the safety and efficacy of Topical Retapamulin Ointment 1%, applied twice daily versus Placebo Ointment in Adults and ...
    Medical condition: Secondarily-infected traumatic lesions (SITL), excluding those with abscesses.
    Disease:
    Population Age: Adolescents, Under 18, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-004886-98 Sponsor Protocol Number: TOC110978 Start Date*: 2017-01-24
    Sponsor Name:GlaxoSmithKline
    Full Title: A Randomized, Double-Blind, Double Dummy, Comparative, Multicenter Study to Assess the Safety and Efficacy of Topical Retapamulin Ointment, 1%, versus Oral Linezolid in the Treatment of Secondarily...
    Medical condition: secondarily-infected traumatic lesions (SITL; excluding abscesses) or impetigo due to methicillin-resistant Staphylococcus aureus (MRSA
    Disease: Version SOC Term Classification Code Term Level
    19.1 10021881 - Infections and infestations 10021531 Impetigo PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-003374-10 Sponsor Protocol Number: TOC106489 Start Date*: 2007-08-03
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: An Open-Label, Non-Comparative Study to Assess the Pharmacokinetics, Safety and Efficacy of Topical Retapamulin (SB-275833) Ointment, 1%, Twice Daily for Five Days in the Treatment of Uncomplicated...
    Medical condition: Uncomplicated skin and skin structure infections
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2011-003032-31 Sponsor Protocol Number: P-110880-01 Start Date*: 2012-02-22
    Sponsor Name:Ferrer Internacional, S.A.
    Full Title: A phase III 3 arms, multicenter, randomised, investigator-blind study to assess the efficacy and safety of ozenoxacin 1% cream applied twice daily for 5 days versus placebo in the treatment of pati...
    Medical condition: Impetigo
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10021531 Impetigo PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-003501-33 Sponsor Protocol Number: DECOLAD Start Date*: 2016-12-01
    Sponsor Name:AntibioTx ApS
    Full Title: A prospective, single center, randomized, double-blind, placebo controlled study in two phases to evaluate the safety and efficacy of ATx201 as a topical antibiotic agent
    Medical condition: AntibioTx has developed a topical product (ATx201) for treatment of infected eczema and infected atopic dermatitis. These infections are predominantly caused by Staphyllococcus aureus and various s...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10040788 Skin and subcutaneous tissue bacterial infections HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2014-000228-52 Sponsor Protocol Number: P-110881-01 Start Date*: 2014-06-03
    Sponsor Name:Ferrer Internacional, SA
    Full Title: A phase III 2 arms, multicenter, randomised, double-blind study to assess the efficacy and safety of ozenoxacin 1% cream applied twice daily for 5 days versus placebo in the treatment of patients w...
    Medical condition: Impetigo
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) RO (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2004-000784-97 Sponsor Protocol Number: SB-275833/032 Start Date*: 2004-02-16
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A Randomized, Double-blind, Double-Dummy, Multicenter, Non-inferiority Phase III Study to Assess the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily, versus Oral Cephalexi...
    Medical condition: Secondarily-Infected Dermatoses
    Disease: Version SOC Term Classification Code Term Level
    7.0 10012470 PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2004-004439-70 Sponsor Protocol Number: TOC100224 Start Date*: 2005-05-20
    Sponsor Name:GlaxSmithKline Research & Development
    Full Title: A Randomised, Observer-blind, Multicentre, Non-inferiority, Comparative Study of the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily for 5 Days, versus Topical 2% Sodium F...
    Medical condition: Impetigo
    Disease: Version SOC Term Classification Code Term Level
    7.1 10021531 PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Prematurely Ended)
    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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