ALTARGO(Retapamulin) PMS(Post-marketing Surveillance)

Completed

• Conditions: Skin Infections, Bacterial
• Interventions: Drug: ALTARGO(retapamulin)

• Registration Number: NCT01445600
• Lead Sponsor: GlaxoSmithKline

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.

ALTARGO is a trademark of the GlaxoSmithKline group of companies.

Study Timeline

• Study First Submitted: 2011-09-21
• Study First Submitted QC: 2011-09-29
• Study First Posted: 2011-10-04
• Study Start: 2012-11
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-21
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3612

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ALTARGO(retapamulin)	ALTARGO(retapamulin)	The subjects with bacterial skin and skin structure infections (SSSI)

Primary Outcome Measures

Name	Time	Method
The number of adverse event after ALTARGO(retapamulin) treatment	14 days

Secondary Outcome Measures

Name	Time	Method
The number of serious adverse event after ALTARGO(retapamulin) treatment	14 days
The number of unexpected adverse event after ALTARGO(retapamulin) treatment	14 days
Effectiveness of ALTARGO(retapamulin) treatment	7 days

Trial Locations

Locations (1)

GSK Investigational Site; 🇰🇷 Seoul, Korea, Republic of