Skip to main content
OpenTrials
Completed

NCT Number: NCT01445600

ALTARGO(Retapamulin) PMS(Post-marketing Surveillance)

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Skin Infections, Bacterial Bacterial Infections Bacterial Infections and Mycoses Cellulitis Connective Tissue Diseases Gram-Positive Bacterial Infections Impetigo Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Staphylococcal Infections Staphylococcal Skin Infections Streptococcal Infections Suppuration

Age range

9 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Seoul, 138-736, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All subjects must satisfy the following criteria at study entry:
  • Subjects administered with ALTARGO(retapamulin) in the topical treatment of the following bacterial skin and skin structure infections (SSSI)
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol and follow the administration regimen
  • 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.
  • Subjects with a known or suspected hypersensitivity to ALTARGO(retapamulin) or any component of the ointment
  • Infants under nine months of age

Treatment and study plan

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.

Primary outcomes

  1. The number of adverse event after ALTARGO(retapamulin) treatment

    Time frame: 14 days

Secondary outcomes

  1. The number of unexpected adverse event after ALTARGO(retapamulin) treatment

    Time frame: 14 days

  2. The number of serious adverse event after ALTARGO(retapamulin) treatment

    Time frame: 14 days

  3. Effectiveness of ALTARGO(retapamulin) treatment

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Acronym: ALTARGOPMS

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 4, 2011
Registry last updated
Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.