Last updated: 11/07/2018 05:42:53

EU PV for Retapamulin-Prescribing

GSK study ID
113149
See study documents
Clinicaltrials.gov ID
NCT01153828
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Pharmacovigilence for retapamulin: Age-stratified monitoring of prescribed use in the European Union
Trial description: Retapamulin, a topical pleuromutilin antibiotic, is the first in a new class of topical antibiotics approved for human use. In the European Union (EU), retapamulin is approved for the treatment of impetigo and secondarily-infected traumatic lesions in persons nine or more months of age. This study is designed to examine retapamulin use in the pediatric population less than nine months of age. We will conduct a five-year assessment of prescriptions for retapamulin using the General Practice Research Database. For each year of reporting, the observed frequencies of prescriptions of retapamulin, with or without same-day co-prescriptions of topical mupirocin or fusidic acid, will be identified. The five-year reporting period will include five years of distinct, non-overlapping, non-cumulative prescription use of first exposure to retapamulin, with or without same-day co-prescription of topical mupirocin or fusidic acid.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Prescription for retapamulin

Timeframe: First prescription in database for each calendar year between January 2007 and December 2011

Secondary outcomes:

Co-prescription of retapamulin and topical mupirocin

Timeframe: First same-day prescriptions for both medicines in database for each calendar year between January 2007 and December 2011

Co-prescription of retapamulin and topical fusidic acid

Timeframe: First same-day prescriptons for both medicines in database for each calendar year between January 2007 and December 2011

Interventions:
  • Drug: Retapamulin
  • Drug: Co-prescription of retapamulin and topical mupirocin
  • Drug: Co-prescription of retapamulin and topical fusidic acid
    • Enrollment:
    1
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Mundy L, Logie J, Sampson T.Retapamulin prescriptions and monitored off-label use.Paediatr Drugs.2014;16(4):331-336
    Medical condition
    Impetigo
    Product
    mupirocin, retapamulin
    Collaborators
    Not applicable
    Study date(s)
    November 2008 to August 2012
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable+ years
    Accepts healthy volunteers
    No
    • The study population will consist of all registered “research standard” patients on GPRD, as evaluated annually for five years. For each year of observation, the denominator of persons will be patients registered for at least one month during the prior calendar year. Hence, the five-year reporting period for distinct, non-overlapping, non-cumulative prescription use and will categorize persons by date of birth (mm/dd/year).
    • Enrollment in GPRD of less than one month duration.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • The study population will consist of all registered “research standard” patients on GPRD, as evaluated annually for five years. For each year of observation, the denominator of persons will be patients registered for at least one month during the prior calendar year. Hence, the five-year reporting period for distinct, non-overlapping, non-cumulative prescription use and will categorize persons by date of birth (mm/dd/year).
    Exclusion criteria:
    • Enrollment in GPRD of less than one month duration.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2012-31-08

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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