Last updated: 07/29/2020 14:00:14
ALTARGO(retapamulin) PMS(post-marketing surveillance)ALTARGOPMS
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
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
Trial description: This is an open label, multi-centre, non-interventional post-marketing surveillance.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
The number of adverse event after ALTARGO(retapamulin) treatment
Timeframe: 14 days
Secondary outcomes:
The number of unexpected adverse event after ALTARGO(retapamulin) treatment
Timeframe: 14 days
The number of serious adverse event after ALTARGO(retapamulin) treatment
Timeframe: 14 days
Effectiveness of ALTARGO(retapamulin) treatment
Timeframe: 7 days
Interventions:
Drug: ALTARGO(retapamulin)
Enrollment:
3612
Observational study model:
Other
Primary completion date:
2015-26-08
Time perspective:
Prospective
Clinical publications:
Woosung Hong, Yil-Seob Lee, Chun Wook Park, Moon-Soo Yoon, Young Suck Ro. An open label, multi-center, non-interventional post-marketing surveillance to monitor the safety and efficacy of ALTARGO® (retapamulin) administered in Korean patients according to the prescribing information. Ann Dermatol. 2018;30(4):441-450.
DOI: 10.5021/ad.2018.30.4.441
Medical condition
Skin Infections, Bacterial, Skin Diseases, Bacterial
Product
retapamulin
Collaborators
Not applicable
Study date(s)
November 2012 to August 2015
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
9+ years
Accepts healthy volunteers
No
- 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)
- 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
Inclusion and exclusion 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
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2015-26-08
Actual study completion date
2015-26-08
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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