Trial record 3 of 144 for:
Open Studies | "Skin Diseases, Infectious"
ALTARGO(Retapamulin) PMS(Post-marketing Surveillance) (ALTARGOPMS)
This study is not yet open for participant recruitment.
Verified January 2013 by GlaxoSmithKline
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01445600
First received: September 21, 2011
Last updated: March 14, 2013
Last verified: January 2013
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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: | Observational Model: Cohort 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:
MedlinePlus related topics:
Skin Infections
Drug Information available for:
Retapamulin
U.S. FDA Resources
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 ]
| Estimated Enrollment: | 4500 |
| Study Start Date: | December 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:
- 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
Contacts and Locations
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: | March 14, 2013 |
| Health Authority: | Korea: Korea Food & Drug Administration |
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 May 21, 2013