ALTARGO(Retapamulin) PMS(Post-marketing Surveillance)
ALTARGOPMS
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
1 other identifier
observational
3,612
1 country
1
Brief Summary
This is an open label, multi-centre, non-interventional post-marketing surveillance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2011
CompletedFirst Posted
Study publicly available on registry
October 4, 2011
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedSeptember 23, 2015
September 1, 2015
2.7 years
September 21, 2011
September 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The number of adverse event after ALTARGO(retapamulin) treatment
14 days
Secondary Outcomes (3)
The number of unexpected adverse event after ALTARGO(retapamulin) treatment
14 days
The number of serious adverse event after ALTARGO(retapamulin) treatment
14 days
Effectiveness of ALTARGO(retapamulin) treatment
7 days
Study Arms (1)
ALTARGO(retapamulin)
The subjects with bacterial skin and skin structure infections (SSSI)
Interventions
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.
Eligibility Criteria
Patients administrated ALTARGO(retapamulin) with primary impetigo or secondarily infected traumatic lesions in Korea
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Investigational Site
Seoul, 138-736, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2011
First Posted
October 4, 2011
Study Start
November 1, 2012
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
September 23, 2015
Record last verified: 2015-09