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OpenTrials
Completed

NCT Number: NCT01153828

EU PV for Retapamulin-Prescribing

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Retapamulin

Drug

Prescription for retapamulin

Co-prescription of retapamulin and topical mupirocin

Drug

Same day prescriptions for retapamulin and topical mupirocin

Co-prescription of retapamulin and topical fusidic acid

Drug

Same day prescription for retapamulin and fusidic acid.

Primary outcomes

  1. Prescription for retapamulin

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

Secondary outcomes

  1. Co-prescription of retapamulin and topical mupirocin

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

  2. Co-prescription of retapamulin and topical fusidic acid

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jun 30, 2010
Registry last updated
Jun 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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