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    Clinical Trial Results:
    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

    Summary
    EudraCT number
    		 2015-004903-22
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    02 Oct 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Dec 2016
    First version publication date
    29 Dec 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TOC110977
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Dec 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Oct 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    TBD
    Protection of trial subjects
    Not Applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 May 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 21
    Country: Number of subjects enrolled
    Brazil: 4
    Country: Number of subjects enrolled
    India: 42
    Country: Number of subjects enrolled
    South Africa: 236
    Country: Number of subjects enrolled
    United States: 204
    Worldwide total number of subjects
    507
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    6
    Children (2-11 years)
    82
    Adolescents (12-17 years)
    34
    Adults (18-64 years)
    362
    From 65 to 84 years
    21
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 508 participants were randomized. One participant did not receive treatment; thus, no data were collected for this participant. Only 507 participants were included in the analysis.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Retapamulin
    Arm description
    		 Topical retapamulin ointment, 1% twice daily for 5 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Retapamulin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    This was provided as approximately 10 grams of an off-white smooth ointment and was applied to the infected lesion(s) at a dose of approximately 10 mg per cm2 twice daily for 5 days; the maximum amount applied per application was to be approximately 1 gram

    Arm title
    		 Placebo
    Arm description
    		 Matching placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    This was provided as approximately 10 grams of an off-white smooth ointment and was applied to the infected lesion(s) at a dose of approximately 10 mg per cm2 twice daily for 5 days; the maximum amount applied per application was to be approximately 1 gram

    Number of subjects in period 1
    		Retapamulin Placebo
    Started
    343
    164
    Completed
    322
    141
    Not completed
    21
    23
         Physician decision
    2
    -
         Consent withdrawn by subject
    1
    2
         Adverse event, non-fatal
    4
    3
         Unknown
    1
    2
         Lost to follow-up
    2
    1
         Lack of efficacy
    10
    15
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Retapamulin
    Reporting group description
    		 Topical retapamulin ointment, 1% twice daily for 5 days

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo

    Reporting group values
    		 Retapamulin Placebo Total
    Number of subjects
    		 343 164
    Age categorical
    Units: Subjects
    Age continuous
    Age continuous description
    Units: years
        arithmetic mean (standard deviation)
    		 32.6 ( 18.77 ) 28.6 ( 18.32 ) -
    Gender categorical
    Gender categorical description
    Units: Subjects
        Female
    		 144 63 207
        Male
    		 199 101 300
    Race/Ethnicity, Customized
    Units: Subjects
        African American/African Heritage
    		 144 71 215
        American Indian or Alaskan Native
    		 9 3 12
        Asian - Central / South Asian Heritage
    		 0 1 1
        Asian - East Asian Heritage
    		 4 2 6
        Asian - South East Asian Heritage
    		 33 15 48
        Native Hawaiian or Other Pacific Islander
    		 1 2 3
        White - Arabic/North African Heritage
    		 1 0 1
        White - White/Caucasian/European Heritage
    		 132 61 193
        Mixed Race
    		 19 9 28

    End points

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    End points reporting groups
    Reporting group title
    Retapamulin
    Reporting group description
    		 Topical retapamulin ointment, 1% twice daily for 5 days

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo

    Primary: Number of Participants with Clinical Success and Failure at Follow-up (7-9 days post therapy) for the Primary Efficacy Population

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    End point title
    		 Number of Participants with Clinical Success and Failure at Follow-up (7-9 days post therapy) for the Primary Efficacy Population
    End point description
    “Clinical Success" at follow-up was defined as "Resolution of clinically meaningful signs and symptoms of infection recorded at baseline including a pus/exudate Skin Infection Rating Scale (SIRS) score of "0". Clinical response at follow-up was classified as "Clinical Failure" for all other cases. The SIRS consists of seven items (pus/exudates, crusting, erythema/inflammation, tissue warmth, tissue edema, itching and pain). Each item has a score ranging from 0 to 6 (0=absent, 6=severe). The SIRS total score was calculated as the sum of the scores of all 7 SIRS items. Primary Efficacy Population:ITTC participants with base line pus/exudate >=3 who were enrolled under the original protocol with data captured under eCRF V1 and who were enrolled under protocol amendments with data captured under eCRF V2; ITTC (Intent-to-treat Clinical): all randomized par. who received at least one dose of study medication.
    End point type
    Primary
    End point timeframe
    Days 12-14
    End point values
    		 Retapamulin Placebo
    Number of subjects analysed
    246 [1]
    113
    Units: participants
        Clinical Success
    184
    75
        Clinical Failure
    62
    38
    Notes
    [1] - Primary Efficacy Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Retapamulin v Placebo
    Number of subjects included in analysis
    359
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.098
    Method
    		 Chi-squared
    Parameter type
    		 Risk difference (RD)
    Point estimate
    8.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 18.4

    Secondary: Number of Participants with Clinical Success and Failure at Follow-up (7-9 days post therapy) for the Intent-to-Treat Bacteriology (ITTB) subset of the Primary Efficacy Population

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    End point title
    		 Number of Participants with Clinical Success and Failure at Follow-up (7-9 days post therapy) for the Intent-to-Treat Bacteriology (ITTB) subset of the Primary Efficacy Population
    End point description
    “Clinical Success" at follow-up was defined as "Resolution of clinically meaningful signs and symptoms of infection recorded at baseline including a pus/exudate Skin Infection Rating Scale (SIRS) score of "0". Clinical response at follow-up was classified as "Clinical Failure" for all other cases. The SIRS consists of seven items (pus/exudates, crusting, erythema/inflammation, tissue warmth, tissue edema, itching and pain). Each item has a score ranging from 0 to 6 (0=absent, 6=severe). The SIRS total score was calculated as the sum of the scores of all 7 SIRS items. ITTB subset of Primary Efficacy Population: participants in the Primary Efficacy Population (see analysis population description in the Primary Outcome section) who had at least one pathogen isolated at the base line visit.
    End point type
    Secondary
    End point timeframe
    Days 12-14
    End point values
    		 Retapamulin Placebo
    Number of subjects analysed
    182 [2]
    84
    Units: participants
        Clinical Success
    139
    54
        Clinical Failure
    43
    30
    Notes
    [2] - ITTB subset of Primary Efficacy Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v Retapamulin
    Number of subjects included in analysis
    266
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.04
    Method
    		 Chi-squared
    Parameter type
    		 Risk difference (RD)
    Point estimate
    12.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 23.6

    Secondary: Number of Participants with Microbiological Success and Failure at Follow-up (7-9 days post therapy)

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    End point title
    		 Number of Participants with Microbiological Success and Failure at Follow-up (7-9 days post therapy)
    End point description
    The "by pathogen" microbiological outcome was determined by comparing the baseline culture results to those at follow-up. The "by subject" microbiological response was "Microbiological Success" if the microbiological outcomes for all baseline pathogens (bps) belong to "Eradication" (elimination of bps), "Presumed Eradication" (clinical outcome was success; no culture was obtained due to lack of culturable material), or "Colonization" (previously unidentified pathogen is identified at end of therapy in participant who is resolved/improved); otherwise, response was "Microbiological Failure".
    End point type
    Secondary
    End point timeframe
    Days 12-14
    End point values
    		 Retapamulin Placebo
    Number of subjects analysed
    182 [3]
    84
    Units: participants
        Microbiological Success
    139
    54
        Microbiological Failure
    43
    30
    Notes
    [3] - ITTB subset of Primary Efficacy Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v Retapamulin
    Number of subjects included in analysis
    266
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.04
    Method
    		 Chi-squared
    Parameter type
    		 Risk difference (RD)
    Point estimate
    12.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 23.6

    Secondary: Number of Participants with the Indicated Clinical Outcome at End of Therapy (2-4 days post therapy)

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    End point title
    		 Number of Participants with the Indicated Clinical Outcome at End of Therapy (2-4 days post therapy)
    End point description
    Clinical outcome is determined by the investigator based on signs and symptoms (S/S) at the end of therapy evaluation. The 4 clincal outcome categories are: clinical success, resolution of clinically meaningful S/S of infection recorded at baseline (BL), including a pus/exudates score of 0; clinical improvement, improvement of S/S of infection recorded at BL to such an extent that no further antimicrobial therapy is necessary; clinical failure, insufficient improvement of deterioration of S/S of infection recorded at BL such that additional antibiotic therapy is required; unable to determine.
    End point type
    Secondary
    End point timeframe
    Days 7-9
    End point values
    		 Retapamulin Placebo
    Number of subjects analysed
    246 [4]
    113
    Units: participants
        Clinical Success
    130
    52
        Clinical Improvement
    102
    45
        Clinical Failure
    11
    14
        Unable to Determine
    3
    2
    Notes
    [4] - Primary Efficacy Population
    No statistical analyses for this end point

    Secondary: Number of Baseline Pathogens with the Indicated Microbiological Outcome at End of Therapy (2-4 days post therapy)

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    End point title
    		 Number of Baseline Pathogens with the Indicated Microbiological Outcome at End of Therapy (2-4 days post therapy)
    End point description
    The "by pathogen" microbiological outcome was determined by comparing the baseline culture results to those at follow-up. The results presented below pooled all baseline pathogens (bps). Eradication: elimination of bps. Presumed Eradication: clinical outcome was success; no culture was obtained due to lack of culturable material. Presumed Improvement: clinical outcome was improvement such that no culture was obtained due to lack of culturable material. Persistence: bps still present. Presumed persistence: clinical failure and no culture was obtained.
    End point type
    Secondary
    End point timeframe
    Days 7-9
    End point values
    		 Retapamulin Placebo
    Number of subjects analysed
    243 [5]
    110
    Units: baseline pathogens
        Eradication
    4
    5
        Presumed Eradication
    137
    49
        Presumed Improvement
    94
    35
        Persistence
    3
    13
        Presumed Persistence
    5
    8
    Notes
    [5] - ITTB subset of Primary Efficacy Population
    No statistical analyses for this end point

    Secondary: Number of Participants with Therapeutic Success and Failure at Follow-up (7-9 days post therapy)

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    End point title
    		 Number of Participants with Therapeutic Success and Failure at Follow-up (7-9 days post therapy)
    End point description
    "Therapeutic Success (Succ)" was referred to as both "Clinical Succ" and "Microbiological (Micro) Succ" at Follow-up. "Clinical Succ" was the "Resolution of baseline signs/symptoms of infection with a pus score of "0." A participant was "Micro Succ" if the micro outcome for all baseline pathogens (bps) belonged to "Eradication" (elimination of bps), "Presumed Eradication" (clinical outcome is success; no culturable material), or "Colonization" (new pathogen is identified at end of therapy in participants who are resolved/improved). All other combinations were deemed "Therapeutic Failures."
    End point type
    Secondary
    End point timeframe
    Follow-up (Days 12-14)
    End point values
    		 Retapamulin Placebo
    Number of subjects analysed
    182 [6]
    84
    Units: participants
        Success
    139
    54
        Failure
    43
    30
    Notes
    [6] - ITTB subset of Primary Efficacy Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs) were recorded from the first dose of study medication until study completion. Serious AEs (SAEs) were collected from the time of consent and continued until study completion (including the Follow-up Period).
    Adverse event reporting additional description
    AEs were collected for all randomized participants (par.) who received at least one dose of study medications (i.e., ITTC Population). Safety data were analyzed based on the actual treatment received. One par. who was randomized to retapamulin treatment but actually received placebo was included in the placebo arm for the safety analyses.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    Retapamulin
    Reporting group description
    		 Topical retapamulin ointment, 1% twice daily for 5 days

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo

    Serious adverse events
    		 Retapamulin Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 342 (0.29%)
    1 / 165 (0.61%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    1 / 342 (0.29%)
    0 / 165 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumococcal pneumonia
         subjects affected / exposed
    0 / 342 (0.00%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Retapamulin Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 342 (2.34%)
    4 / 165 (2.42%)
    Injury, poisoning and procedural complications
    Wound secretion
         subjects affected / exposed
    1 / 342 (0.29%)
    0 / 165 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Tension headache
         subjects affected / exposed
    0 / 342 (0.00%)
    1 / 165 (0.61%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Application site pain
         subjects affected / exposed
    5 / 342 (1.46%)
    0 / 165 (0.00%)
         occurrences all number
    5
    0
    Condition aggravated
         subjects affected / exposed
    3 / 342 (0.88%)
    1 / 165 (0.61%)
         occurrences all number
    3
    1
    Pyrexia
         subjects affected / exposed
    0 / 342 (0.00%)
    3 / 165 (1.82%)
         occurrences all number
    0
    3
    Application site paraesthesia
         subjects affected / exposed
    1 / 342 (0.29%)
    0 / 165 (0.00%)
         occurrences all number
    1
    0
    Application site pruritus
         subjects affected / exposed
    1 / 342 (0.29%)
    0 / 165 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Eye pruritus
         subjects affected / exposed
    1 / 342 (0.29%)
    0 / 165 (0.00%)
         occurrences all number
    1
    0
    Ocular hyperaemia
         subjects affected / exposed
    1 / 342 (0.29%)
    0 / 165 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 342 (0.00%)
    1 / 165 (0.61%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 342 (0.29%)
    0 / 165 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    1 / 342 (0.29%)
    0 / 165 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 342 (0.29%)
    0 / 165 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 342 (0.29%)
    0 / 165 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Abscess
         subjects affected / exposed
    1 / 342 (0.29%)
    0 / 165 (0.00%)
         occurrences all number
    1
    0
    Cellulitis
         subjects affected / exposed
    0 / 342 (0.00%)
    1 / 165 (0.61%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 342 (0.29%)
    0 / 165 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 342 (0.00%)
    1 / 165 (0.61%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Nov 2008
    This amendment was conducted to: make a change to the entry criterion regarding minimum pus/exudate SIRS score; revise the exclusion criterion regarding surgical intervention and other investigational drug use; amend information provided in the introduction; and, re-define and re-classify clinical and microbiological outcomes at the end of therapy and follow-up visits.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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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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