ALTARGO(Retapamulin) PMS(Post-marketing Surveillance)
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Skin Infections, Bacterial
Intervention: ALTARGO(retapamulin) (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Overall contact:
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
Summary
This is an open label, multi-centre, non-interventional post-marketing surveillance.
Clinical Details
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 design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: The number of adverse event after ALTARGO(retapamulin) treatment
Secondary outcome: The number of unexpected adverse event after ALTARGO(retapamulin) treatmentThe number of serious adverse event after ALTARGO(retapamulin) treatment
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.
ALTARGO is a trademark of the GlaxoSmithKline group of companies.
Eligibility
Minimum age: 9 Months.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- All subjects must satisfy the following criteria at study entry:
1. Subjects administered with ALTARGO(retapamulin) in the topical treatment of the
following bacterial skin and skin structure infections (SSSI)
2. Subjects who the investigator believes that they can and will comply with the
requirements of the protocol and follow the administration regimen
3. Subjects administered with ALTARGO(retapamulin) following the locally approved
prescribing information
Exclusion Criteria:
- 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.
1. Subjects with a known or suspected hypersensitivity to ALTARGO(retapamulin) or
any component of the ointment
2. Infants under nine months of age
Locations and Contacts
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
GSK Investigational Site, Seoul 138-736, Korea, Republic of; Not yet recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com
Additional Information
Starting date: December 2012
Last updated: January 21, 2013
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