EU PV for Retapamulin-Prescribing

Impetigo Clinical Trial

Official title:

Pharmacovigilence for Retapamulin: Age-stratified Monitoring of Prescribed Use in the European Union

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01153828
• Other study ID #: 113149
• Status: Completed
• Phase: N/A
• First received: May 13, 2010
• Last updated: June 6, 2013
• Start date: November 2008
• Est. completion date: August 2012

Study information

• Verified date: May 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: No Health Authority
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Impetigo

Intervention

Drug:
• Retapamulin
Prescription for retapamulin
• Co-prescription of retapamulin and topical mupirocin
Same day prescriptions for retapamulin and topical mupirocin
• Co-prescription of retapamulin and topical fusidic acid
Same day prescription for retapamulin and fusidic acid.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prescription for retapamulin		First prescription in database for each calendar year between January 2007 and December 2011	Yes
Secondary	Co-prescription of retapamulin and topical mupirocin		First same-day prescriptions for both medicines in database for each calendar year between January 2007 and December 2011	Yes
Secondary	Co-prescription of retapamulin and topical fusidic acid		First same-day prescriptons for both medicines in database for each calendar year between January 2007 and December 2011	Yes