An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance (PMS) to Monitor the Safety and Efficacy of ALTARGO(Retapamulin) Administered in Korean Patients According to the Prescribing Information

GlaxoSmithKline1 site in 1 country3,612 target enrollmentNovember 2012

ConditionsSkin Infections, Bacterial

InterventionsALTARGO(retapamulin)

DrugsALTARGO(retapamulin)

Overview

Phase: Not Applicable
Intervention: ALTARGO(retapamulin)
Conditions: Skin Infections, Bacterial
Sponsor: GlaxoSmithKline
Enrollment: 3612
Locations: 1
Primary Endpoint: The number of adverse event after ALTARGO(retapamulin) treatment
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open label, multi-centre, non-interventional post-marketing surveillance.

Detailed Description

This is an open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety of ALTARGO(retapamulin) treated in Korean patients according to the prescribing information. ALTARGO is a trademark of the GlaxoSmithKline group of companies.

Registry

clinicaltrials.gov

Start Date

November 2012

End Date

August 2015

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•All subjects must satisfy the following criteria at study entry:
•Subjects administered with ALTARGO(retapamulin) in the topical treatment of the following bacterial skin and skin structure infections (SSSI)
•Subjects who the investigator believes that they can and will comply with the requirements of the protocol and follow the administration regimen
•Subjects administered with ALTARGO(retapamulin) following the locally approved prescribing information

Exclusion Criteria

•Considering the nature of observational study, GSK Korea encourages the doctors participating in this study to enrol the subjects prescribed with retapamulin following the locally approved Prescribing Information.
•Subjects with a known or suspected hypersensitivity to ALTARGO(retapamulin) or any component of the ointment
•Infants under nine months of age

Arms & Interventions

ALTARGO(retapamulin)

The subjects with bacterial skin and skin structure infections (SSSI)

Intervention: ALTARGO(retapamulin)

Outcomes

Primary Outcomes

The number of adverse event after ALTARGO(retapamulin) treatment

Time Frame: 14 days

Secondary Outcomes

The number of serious adverse event after ALTARGO(retapamulin) treatment(14 days)
The number of unexpected adverse event after ALTARGO(retapamulin) treatment(14 days)
Effectiveness of ALTARGO(retapamulin) treatment(7 days)