United States Pharmacovigilence Retapamulin-Prescribing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01153880
First received: June 29, 2010
Last updated: June 6, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Skin Infections, Bacterial
Drug: Retapamulin
Drug: Co-prescription of retapamulin and topical mupirocin

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Pharmacovigilence for Retapamulin: Age-stratified Monitoring of Prescribed Use in the United States

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Prescription of retapamulin [ Time Frame: First prescription in database for each calendar year between January 2007 and December 2011 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Prescription for retapamulin and topical mupirocin [ Time Frame: First same-day prescriptions for both medicines in database for each calendar year between Janaury 2007 and December 2011 ] [ Designated as safety issue: Yes ]

Enrollment: 1
Study Start Date: December 2008
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Age <9 months definitive
Age at time of prescription was <9 months
Drug: Retapamulin
Prescription sales claim of retapamulin
Drug: Co-prescription of retapamulin and topical mupirocin
Same day prescription sales claims for retapamulin and topical mupirocin
Age <9 months uncertain
Age at time of prescription was uncertain for <9 months
Drug: Retapamulin
Prescription sales claim of retapamulin
Drug: Co-prescription of retapamulin and topical mupirocin
Same day prescription sales claims for retapamulin and topical mupirocin
9 months to 6 years
Age at time of prescription was 9 months to 6 years
Drug: Retapamulin
Prescription sales claim of retapamulin
Drug: Co-prescription of retapamulin and topical mupirocin
Same day prescription sales claims for retapamulin and topical mupirocin
7 to 18 years
Age at time of prescription was 7 to 18 years
Drug: Retapamulin
Prescription sales claim of retapamulin
Drug: Co-prescription of retapamulin and topical mupirocin
Same day prescription sales claims for retapamulin and topical mupirocin
19 to 65 years
Age at time of prescription was 19 to 65 years
Drug: Retapamulin
Prescription sales claim of retapamulin
Drug: Co-prescription of retapamulin and topical mupirocin
Same day prescription sales claims for retapamulin and topical mupirocin
66 years and older
Age at time of prescription was 66 years and older
Drug: Retapamulin
Prescription sales claim of retapamulin
Drug: Co-prescription of retapamulin and topical mupirocin
Same day prescription sales claims 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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Members with enrollment and phamacy benefits eligibility in the Integrated Health Care Information Services (IHCIS) National Managed Care Benchmarked Database will be assessed annually for prescription sales claims for five years post-launch of retapamulin. The IHCIS is a US national managed care database which is Health Insurance Portability and Accountability Act (HIPAA) compliant and features encrypted member and provider identifiers.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01153880

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01153880     History of Changes
Other Study ID Numbers: 113158
Study First Received: June 29, 2010
Last Updated: June 6, 2013
Health Authority: United States: No Health Authority

Keywords provided by GlaxoSmithKline:
Altabax
United States
topical
Mupirocin
Retapamulin
Bactroban

Additional relevant MeSH terms:
Bacterial Infections
Skin Diseases, Infectious
Infection
Skin Diseases
Mupirocin
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014