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    Summary
    EudraCT Number:2015-004903-22
    Sponsor's Protocol Code Number:TOC110977
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-12-12
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2015-004903-22
    A.3Full title of the trial
    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 Children in the treatment of Secondarily- Infected Traumatic Lesions - Centralised - Study only identified as requiring Article 46 submission - 30 July 2012 (as part of comparator/co-administration retrospective exercise)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study todemonstrate clinical superiority of retapamulin ointment, 1%, over placebo in patients with secondarily-infected traumatic lesions (SITL).
    A.4.1Sponsor's protocol code numberTOC110977
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline Research & Development Ltd
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGlaxoSmithKline
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmtihKline Research & Development Ltd.
    B.5.2Functional name of contact pointGSK Clinical Support Help Desk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11-1BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4408007839733
    B.5.6E-mailGSKClinicalSupportHD@gsk.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Altargo,Altabax; Altargo,Altabax,Altarog
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Ointment
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRETAPAMULIN
    D.3.9.1CAS number 224452-66-8
    D.3.9.2Current sponsor codeRETAPAMULIN
    D.3.9.3Other descriptive nameRETAPAMULIN
    D.3.9.4EV Substance CodeSUB25391
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Secondarily-infected traumatic lesions (SITL),
    excluding those with abscesses.
    E.1.1.1Medical condition in easily understood language
    Skin Infections
    E.1.1.2Therapeutic area Body processes [G] - Microbiological Phenomena [G06]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study was to demonstrate that topical retapamulin was clinically superior to placebo in the treatment of subjects with SITL.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study were to evaluate the safety and bacteriological efficacy of retapamulin versus placebo in the treatment of SITL.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - subject is aged 2 months or older
    - subject has secondarily-infected traumatic lesion (laceration, sutured wound or abrasion)
    - negative urine pregnancy test
    - subject has total skin infection rating scale score of at least 8, including pus/exudate score of at least 3
    - subject and/or parent/legal guardian is willing and able to comply with protocol
    - subject or parent/legal guardian has given written informed consent or assent as applicable
    E.4Principal exclusion criteria
    - previous hypersensitivity to pleuromutilin
    - secondarily-infected animal/human bite or puncture wound
    - subject has an abscess
    - chronic ulcerative lesion
    - underlying skin disease
    - systemic signs and symptoms of infection
    - infection not appropriately treated with topical antibiotic
    - infection requires surgical intervention prior to or during study
    - subject received systemic antibacterial or steroid, or topical therapeutic agent within 24 hours of entry into study
    - serious underlying disease
    - subject pregnant, breast feeding or planning a pregnancy, or unacceptable method of contraception
    - other investigational drug within 30 days of study entry
    - subject previously enrolled in this study
    E.5 End points
    E.5.1Primary end point(s)
    Clinical response at follow-up (Day 12-14)in the intent-to-treat clinical population.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time Frame: 12-14 days after baseline
    E.5.2Secondary end point(s)
    •Microbiological response at follow-up (Day 12-14)
    Time Frame: 12-14 days after baseline
    •Microbiological outcome at end of therapy (Day 7-9)
    Time Frame: 7-9 days after baseline
    •Therapeutic response at follow-up (Day 12-14)
    Time Frame: 12-14 days after baseline
    •Clinical outcome at end of therapy (Day 7-9)
    Time Frame: 7-9 days after baseline
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Microbiological response at follow-up (Day 12-14)
    Time Frame: 12-14 days after baseline
    •Microbiological outcome at end of therapy (Day 7-9)
    Time Frame: 7-9 days after baseline
    •Therapeutic response at follow-up (Day 12-14)
    Time Frame: 12-14 days after baseline
    •Clinical outcome at end of therapy (Day 7-9)
    Time Frame: 7-9 days after baseline
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial days14
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 83
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 83
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 35
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 366
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Peadiatrics
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 508
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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