ALTARGO(Retapamulin) PMS(Post-marketing Surveillance) (ALTARGOPMS)
|Study Design:||Time Perspective: Prospective|
|Official Title:||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|
- The number of adverse event after ALTARGO(retapamulin) treatment [ Time Frame: 14 days ]
- The number of unexpected adverse event after ALTARGO(retapamulin) treatment [ Time Frame: 14 days ]
- The number of serious adverse event after ALTARGO(retapamulin) treatment [ Time Frame: 14 days ]
- Effectiveness of ALTARGO(retapamulin) treatment [ Time Frame: 7 days ]
|Study Start Date:||November 2012|
|Study Completion Date:||August 2015|
|Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
The subjects with bacterial skin and skin structure infections (SSSI)
Basically there is no treatment allocation. Subjects who would be administered of ALTARGO(retapamulin) at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01445600
|Korea, Republic of|
|GSK Investigational Site|
|Seoul, Korea, Republic of, 138-736|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|