ALTARGO(Retapamulin) PMS(Post-marketing Surveillance) (ALTARGOPMS)
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|ClinicalTrials.gov Identifier: NCT01445600|
Recruitment Status : Completed
First Posted : October 4, 2011
Last Update Posted : September 23, 2015
|Condition or disease||Intervention/treatment|
|Skin Infections, Bacterial||Drug: ALTARGO(retapamulin)|
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.
|Study Type :||Observational|
|Actual Enrollment :||3612 participants|
|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|
|Study Start Date :||November 2012|
|Primary Completion Date :||August 2015|
|Study Completion Date :||August 2015|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01445600
|Korea, Republic of|
|GSK Investigational Site|
|Seoul, Korea, Republic of, 138-736|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|