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

September 21, 2015 updated by: GlaxoSmithKline

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

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

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Observational

Enrollment (Actual)

3612

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ALTARGO(retapamulin)
The subjects with bacterial skin and skin structure infections (SSSI)
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
The number of unexpected adverse event after ALTARGO(retapamulin) treatment
Time Frame: 14 days
14 days
The number of serious adverse event after ALTARGO(retapamulin) treatment
Time Frame: 14 days
14 days
Effectiveness of ALTARGO(retapamulin) treatment
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ACTUAL)

August 1, 2015

Study Completion (ACTUAL)

August 1, 2015

Study Registration Dates

First Submitted

September 21, 2011

First Submitted That Met QC Criteria

September 29, 2011

First Posted (ESTIMATE)

October 4, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 21, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 115579

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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