United States Pharmacovigilence Retapamulin-Prescribing

Skin Infections, Bacterial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01153880
• Other study ID #: 113158
• Status: Completed
• Phase: N/A
• First received: June 29, 2010
• Last updated: June 6, 2013
• Start date: December 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 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.

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).

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 '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.

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Bacterial Infections
• Skin Diseases, Infectious
• Skin Infections, Bacterial

Intervention

Drug:
• Retapamulin
Prescription sales claim of retapamulin
• Co-prescription of retapamulin and topical mupirocin
Same day prescription sales claims for retapamulin and topical mupirocin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

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