Skin Infections, BacterialALTARGOPMSNCT01445600
ALTARGO(Retapamulin) PMS(Post-marketing Surveillance)
An observational study of Skin Infections, Bacterial, run by GlaxoSmithKline at 1 site in South Korea.
Trial summary
This is an open label, multi-centre, non-interventional post-marketing surveillance. Read more about this study
- Who is it for?
- Ages 9 months and older
- Conditions the study is for
- Skin Infections, Bacterial
- What is being tested?
- ALTARGO(retapamulin)
- How many people
- 3,612 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2012to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients administrated ALTARGO(retapamulin) with primary impetigo or secondarily infected traumatic lesions in Korea
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
This is an open label, multi-centre, non-interventional post-marketing surveillance.
Read the 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.
- Conditions
- Skin Infections, Bacterial
- Being tested
- ALTARGO(retapamulin)
- Keywords
- Impetigo, secondarily-infected traumatic lesions, retapamulin
- Medical subject headings
- Cellulitis, Impetigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| ALTARGO(retapamulin) | The subjects with bacterial skin and skin structure infections (SSSI) Receives: Drug: ALTARGO(retapamulin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of adverse event after ALTARGO(retapamulin) treatment
Measured: 14 days
Secondary outcomes (3)
The number of unexpected adverse event after ALTARGO(retapamulin) treatment
Measured: 14 days
The number of serious adverse event after ALTARGO(retapamulin) treatment
Measured: 14 days
Effectiveness of ALTARGO(retapamulin) treatment
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2011 (estimated)
- Study startNov 2012
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Infections, BacterialStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 3,612 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01445600
- Sponsor's protocol ID
- 115579
- Acronym
- ALTARGOPMS
- Status last verified
- Sep 2015
- First submitted
- 21 Sep 2011
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01445600
- Acronym / sponsor ID
- ALTARGOPMS / 115579
- Conditions
- Skin Infections, Bacterial
- Keywords
- Impetigo, secondarily-infected traumatic lesions, retapamulin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,612 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 4 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label, multi-centre, non-interventional post-marketing surveillance.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALTARGO(retapamulin) | – | Drug: ALTARGO(retapamulin)The subjects with bacterial skin and skin structure infections (SSSI) |
Who may qualify
- Ages
- 9 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients administrated ALTARGO(retapamulin) with primary impetigo or secondarily infected traumatic lesions in Korea
Key inclusion criteria (4 listed)
- All subjects must satisfy the following criteria at study entry:
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | ALTARGO(retapamulin) |
Primary outcome
The number of adverse event after ALTARGO(retapamulin) treatment
Time frame: 14 days
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Infections, Bacterial, run by GlaxoSmithKline at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of adverse event after ALTARGO(retapamulin) treatment (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.