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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01445600
First Posted: October 4, 2011
Last Update Posted: September 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
This is an open label, multi-centre, non-interventional post-marketing surveillance.

Condition Intervention
Skin Infections, Bacterial Drug: ALTARGO(retapamulin)

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The number of adverse event after ALTARGO(retapamulin) treatment [ Time Frame: 14 days ]

Secondary Outcome Measures:
  • The number of unexpected adverse event after ALTARGO(retapamulin) treatment [ Time Frame: 14 days ]
  • The number of serious adverse event after ALTARGO(retapamulin) treatment [ Time Frame: 14 days ]
  • Effectiveness of ALTARGO(retapamulin) treatment [ Time Frame: 7 days ]

Enrollment: 3612
Study Start Date: November 2012
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   9 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients administrated ALTARGO(retapamulin) with primary impetigo or secondarily infected traumatic lesions in Korea
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01445600


Locations
Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01445600     History of Changes
Other Study ID Numbers: 115579
First Submitted: September 21, 2011
First Posted: October 4, 2011
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by GlaxoSmithKline:
Impetigo
secondarily-infected traumatic lesions
retapamulin

Additional relevant MeSH terms:
Skin Diseases, Infectious
Bacterial Infections
Infection
Skin Diseases