ALTARGO(Retapamulin) PMS(Post-marketing Surveillance) | NCT01445600

Studies
ALTARGO(Retapamulin) PMS(Post-marketing Surveillance)

NCT01445600

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Sep 23, 2015Estimated

Enrollment

3,612Actual

Phase

Not provided

Conditions

Skin Infections, Bacterial

Interventions

ALTARGO(retapamulin)

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Aug 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

Sep 21, 2011

First Submission Date that Met QC Criteria

Sep 29, 2011

First Posted Date

Oct 4, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2015

Last Update Posted Date

Sep 23, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,612Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ALTARGO(retapamulin)		The subjects with bacterial skin and skin structure infections (SSSI)	Drug: ALTARGO(retapamulin)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ALTARGO(retapamulin)	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of adverse event after ALTARGO(retapamulin) treatment		14 days

Secondary Outcomes

Measure	Description	Time Frame
The number of unexpected adverse event after ALTARGO(retapamulin) treatment		14 days
The number of serious adverse event after ALTARGO(retapamulin) treatment		14 days

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Months

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients administrated ALTARGO(retapamulin) with primary impetigo or secondarily infected traumatic lesions in Korea

Sampling Method

Probability Sample

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Seoul		138-736	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D002481	Cellulitis
D007169	Impetigo

Ancestor Terms

ID	Term
D012874	Skin Diseases, Infectious
D007239	Infections
D013492	Suppuration
D003240	Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided