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CompletedNCT01153828Updated Jun 10, 2013

EU PV for Retapamulin-Prescribing

An observational study in Impetigo, sponsored by GlaxoSmithKline. Completed. Per ClinicalTrials.gov, last updated 2013-06-10.

Sponsored by GlaxoSmithKline · Observational

Study type
Observational
Time perspective
Retrospective
Enrollment
1
Sex
All
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Study summary

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.

02

Conditions studied

  • Impetigo

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Keywords

  • Altargo
  • Bactroban
  • Fucidin
  • Fusidic acid
  • Mupirocin
  • topical
  • Retapamulin
  • United Kingdom
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In context

Impetigo

27 studies on the registry are indexed under Impetigo; 3 are open to participants now.

Browse Impetigo studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 120 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 240 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The GPRD contains detailed information for a sample of patients from representative general practices throughout the United Kingdom. Patient data included in the GPRD were drawn from the computer systems used by general practitioners to maintain the clinical records within their practices and contain all records deemed relevant to patient care. Prescriptions of Altabax, Altargo, Mupirocin and Fucidin will be captured.

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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

Exclusion Criteria:

  • Enrollment in GPRD of less than one month duration.
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Study design

Time perspective
Retrospective
Enrollment
1 participant (actual)

Groups and cohorts

  • (1) Age <9 months

    Age at time of prescription was \<9 months

    Drug: Retapamulin · Drug: Co-prescription of retapamulin and topical mupirocin · Drug: Co-prescription of retapamulin and topical fusidic acid

  • (2) 9 months to 6 years

    Age at time of prescription was 9 months to 6 years

    Drug: Retapamulin · Drug: Co-prescription of retapamulin and topical mupirocin · Drug: Co-prescription of retapamulin and topical fusidic acid

  • (3) 7 years to 18 years

    Age at time of prescription was 7 years to 18 years

    Drug: Retapamulin · Drug: Co-prescription of retapamulin and topical mupirocin · Drug: Co-prescription of retapamulin and topical fusidic acid

  • (4) 19 to 65 years

    Age at time of prescription was 19 to 65 years

    Drug: Retapamulin · Drug: Co-prescription of retapamulin and topical mupirocin · Drug: Co-prescription of retapamulin and topical fusidic acid

  • (5) 66 years and older

    Age at time of prescription was 66 years and older

    Drug: Retapamulin · Drug: Co-prescription of retapamulin and topical mupirocin · Drug: Co-prescription of retapamulin and topical fusidic acid

Interventions

  • Prescription for retapamulin

  • DrugCo-prescription of retapamulin and topical mupirocin

    Same day prescriptions for retapamulin and topical mupirocin

  • DrugCo-prescription of retapamulin and topical fusidic acid

    Same day prescription for retapamulin and fusidic acid.

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What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2008, a primary completion of Aug 2012 and a completion of Aug 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 13, 2010
First posted
Jun 30, 2010
Start
Nov 2008
Primary completionActual
Aug 2012
CompletionActual
Aug 2012
Last update
Jun 10, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 10, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01153828
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jun 30, 2010
Start date
Nov 2008
Primary completion
Aug 2012
Completion
Aug 2012
Last update
Jun 10, 2013

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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