ALTARGO(Retapamulin) PMS(Post-marketing Surveillance)

Skin Infections, Bacterial Clinical Trial

— ALTARGOPMS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01445600
• Other study ID #: 115579
• Status: Completed
• Phase: N/A
• First received: September 21, 2011
• Last updated: September 21, 2015
• Start date: November 2012
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: MFDS(Ministry of Food and Drug Safety)
• Study type: Observational

Clinical Trial Summary

This is an open label, multi-centre, non-interventional post-marketing surveillance.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3612
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Months and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Bacterial Infections
• Skin Diseases, Infectious
• Skin Infections, Bacterial

Intervention

Drug:
• ALTARGO(retapamulin)
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.

Locations

Country	Name	City	State
Korea, Republic of	GSK Investigational Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of adverse event after ALTARGO(retapamulin) treatment		14 days	No
Secondary	The number of unexpected adverse event after ALTARGO(retapamulin) treatment		14 days	No
Secondary	The number of serious adverse event after ALTARGO(retapamulin) treatment		14 days	No
Secondary	Effectiveness of ALTARGO(retapamulin) treatment		7 days	No