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United States Pharmacovigilence Retapamulin-Prescribing

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Skin Infections, Bacterial

Intervention: Retapamulin (Drug); Co-prescription of retapamulin and topical mupirocin (Drug)

Phase: N/A

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

Retapamulin, a topical pleuromutilin antibiotic, is the first in a new class of topical antibiotics approved for human use. In the United States (US), retapamulin is approved for the treatment of impetigo in persons nine or more months of age and was launched on 12 April 2007. This five-year study is designed to examine use of retapamulin in the pediatric population less than nine months of age. We will conduct an annual assessment of prescription sales claims for retapamulin using the Integrated Health Care Information Services (IHCIS) National Managed Care Benchmarked Database. For each year of reporting, the observed frequencies of the exposure, with or without same-day, co-prescribed sales claim of mupirocin, will be identified. The study objectives are to determine the frequency of retapamulin sales in a representative US population stratified by the designated age group and to determine the frequency of same-day sale of the topical agent, mupirocin.

Clinical Details

Official title: Pharmacovigilence for Retapamulin: Age-stratified Monitoring of Prescribed Use in the United States

Study design: Time Perspective: Retrospective

Primary outcome: Prescription of retapamulin

Secondary outcome: Prescription for retapamulin and topical mupirocin

Detailed description: The IHCIS is Health Insurance Portability and Accountability Act (HIPAA) compliant with encrypted member and provider identifiers; date of birth is restricted to year of birth. Based on year of birth and the prescription sales claim date, age at the time of the prescription(s) will be categorized as less than 9 months (definitive) and less than 9 months (uncertain).

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- The study population will consist of all 'eligible members' in the IHCIS database

with a valid gender and age record who have at least 1 month enrolment and eligibility of pharmacy benefits. Exclusion Criteria:

- Membership in IHCIS without a valid gender or age record, enrolment less than 1

month, or ineligibility for pharmacy benefits will be excluded.

Locations and Contacts

Additional Information

Starting date: December 2008
Last updated: June 6, 2013

Page last updated: August 23, 2015

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