Trial record 3 of 172 for:    Open Studies | "Skin Diseases, Infectious"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01445600
First received: September 21, 2011
Last updated: July 24, 2014
Last verified: July 2014
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of unexpected adverse event after ALTARGO(retapamulin) treatment [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • The number of serious adverse event after ALTARGO(retapamulin) treatment [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Effectiveness of ALTARGO(retapamulin) treatment [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 3000
Study Start Date: November 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 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.
Other Name: ALTARGO(retapamulin)

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

Ages Eligible for Study:   9 Months and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01445600

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
Korea, Republic of
GSK Investigational Site Recruiting
Seoul, Korea, Republic of, 138-736
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01445600     History of Changes
Other Study ID Numbers: 115579
Study First Received: September 21, 2011
Last Updated: July 24, 2014
Health Authority: Korea: MFDS(Ministry of Food and Drug Safety)

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

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

ClinicalTrials.gov processed this record on August 21, 2014