Last updated: 11/07/2018 05:43:44
United States Pharmacovigilence Retapamulin-Prescribing
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Pharmacovigilence for Retapamulin: Age-stratified monitoring of prescribed use in the United States
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Prescription of retapamulin
Timeframe: First prescription in database for each calendar year between January 2007 and December 2011
Secondary outcomes:
Prescription for retapamulin and topical mupirocin
Timeframe: First same-day prescriptions for both medicines in database for each calendar year between Janaury 2007 and December 2011
Interventions:
Enrollment:
1
Primary completion date:
Not applicable
Observational study model:
Other
Time perspective:
Retrospective
Clinical publications:
Mundy L, Logie J, Sampson T.Retapamulin prescriptions and monitored off-label use.Paediatr Drugs.2014;16(4):331-336
Medical condition
Skin Infections, Bacterial
Product
mupirocin, retapamulin
Collaborators
Not applicable
Study date(s)
December 2008 to August 2012
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable+ years
Accepts healthy volunteers
No
- 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.
- Membership in IHCIS without a valid gender or age record, enrolment less than 1 month, or ineligibility for pharmacy benefits will be excluded.
Inclusion and exclusion 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.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2012-31-08
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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