Status:

COMPLETED

ALTARGO(Retapamulin) PMS(Post-marketing Surveillance)

Lead Sponsor:

GlaxoSmithKline

Conditions:

Skin Infections, Bacterial

Eligibility:

All Genders

9+ years

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. ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 1 2012

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

August 1 2015

Estimated Enrollment :

3612 Patients enrolled

Trial Details

Trial ID

NCT01445600

Start Date

November 1 2012

End Date

August 1 2015

Last Update

September 23 2015

Active Locations (1)

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1

GSK Investigational Site

Seoul, South Korea, 138-736