Last updated: 11/07/2018 05:42:53
EU PV for Retapamulin-Prescribing
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Other
Primary completion date:
Not applicable
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)
No location data available.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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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