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