ImpetigoPhase 3NCT00133848
Treatment Of Impetigo With Topical SB-275833 Ointment, 1% Versus Topical Placebo Ointment
A Phase 3 study testing SB-275833 ointment, 1% in people with Impetigo, run by GlaxoSmithKline at 22 sites in 5 countries.
Trial summary
The goal of this study is to determine if topical SB-275833 ointment, 1% is more effective than a placebo ointment in the treatment of primary impetigo. Read more about this study
- Who is it for?
- Ages 9 months and older
- Conditions the study is for
- Impetigo
- What is being tested?
- SB-275833 ointment, 1%
- How many people
- 210 participants
- Where
- 22 sitesin 5 countries
- Study dates
- Apr 2005to Jan 2006
- Phase
- Phase 3
- 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
Who may be able to join
- Must have primary impetigo with total lesion area being 100 square centimeters or less.
- Women who could bear children must have a negative urine pregnancy test and agree to either abstain from sexual intercourse or the use of specific effective contraceptive measures.
Who cannot join
- Any signs and symptoms of systemic infection.
- Any serious underlying disease that could be imminently life threatening.
Trial locations and contacts
22 sites in 5 countries.
22 sites in 5 countries
Netherlands15 sites
GSK Investigational Site
Beek en Donk, 5741 CG
GSK Investigational Site
Deurne, 5751 XJ
GSK Investigational Site
Ermelo, 3851 EX
GSK Investigational Site
Gouda, 2806 DA
GSK Investigational Site
Musselkanaal, 9581 AD
GSK Investigational Site
Musselkanaal, 9581 AJ
GSK Investigational Site
Nijmegen, 6531 NB
GSK Investigational Site
Nijverdal, 7442 LS
GSK Investigational Site
Roelofarendsveen, 2371 RB
GSK Investigational Site
Rotterdam, 3015 GE
GSK Investigational Site
Rotterdam, 3082 DC
GSK Investigational Site
Soerendonk, 6027 RN
GSK Investigational Site
Woerden, 3443 GG
GSK Investigational Site
Zieuwent, 7136 KH
GSK Investigational Site
Zwijndrecht, 3331 LZ
India2 sites
GSK Investigational Site
Bangalore, 560 054
GSK Investigational Site
Hyderabad, 40000
Mexico2 sites
GSK Investigational Site
Mexico City, 06780
GSK Investigational Site
Zapopan, Jalisco, Jalisco, 45190
Peru2 sites
GSK Investigational Site
Callao, Provincia Constitucional del Callao, Callao 1
GSK Investigational Site
Lima, Lima 31
About this study
Official title: A Randomised, Double-blind, Multicentre, Superiority Placebo-controlled, Phase III Study to Assess the Efficacy and Safety of Topical 1% SB-275833 Ointment Versus Placebo Ointment Applied Twice Daily for 5 Days in the Treatment of Adults and Paediatric Subjects With Impetigo.
The goal of this study is to determine if topical SB-275833 ointment, 1% is more effective than a placebo ointment in the treatment of primary impetigo.
- Conditions
- Impetigo
- Being tested
- SB-275833 ointment, 1%
- Keywords
- impetigo, topical antibacterial, topical antibiotic
- Medical subject headings
- Impetigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB-275833 ointment, 1%Drug
Also called SB-275833 ointment, 1%
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response of impetigo at end of therapy visit. Clinical response of success is defined as no further need for antibacterial treatment.
Secondary outcomes (1)
Clinical response of impetigo at follow up visit. Impetigo lesion area at end of therapy and follow up visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2005 (estimated)
- Study startApr 2005
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImpetigoStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 210 participants
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
- NCT00133848
- Sponsor's protocol ID
- TOC103469
- Status last verified
- Sep 2016
- First submitted
- 22 Aug 2005
- Last updated
- 23 Sep 2016
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Multicentre, Superiority Placebo-controlled, Phase III Study to Assess the Efficacy and Safety of Topical 1% SB-275833 Ointment Versus Placebo Ointment Applied Twice Daily for 5 Days in the Treatment of Adults and Paediatric Subjects With Impetigo.
- ClinicalTrials.gov ID
- NCT00133848
- Acronym / sponsor ID
- TOC103469
- Conditions
- Impetigo
- Keywords
- impetigo, topical antibacterial, topical antibiotic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Study completion
- Jan 2006 (actual)
- First posted
- 24 Aug 2005 (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.
The goal of this study is to determine if topical SB-275833 ointment, 1% is more effective than a placebo ointment in the treatment of primary impetigo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 9 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Must have primary impetigo with total lesion area being 100 square centimeters or less.
- Women who could bear children must have a negative urine pregnancy test and agree to either abstain from sexual intercourse or the use of specific effective contraceptive measures.
Key exclusion criteria (2 listed)
- Any signs and symptoms of systemic infection.
- Any serious underlying disease that could be imminently life threatening.
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 |
|---|---|---|
| SB-275833 ointment, 1%Also: SB-275833 ointment, 1% | Drug | – |
Primary outcome
Clinical response of impetigo at end of therapy visit. Clinical response of success is defined as no further need for antibacterial treatment.
1 secondary outcome
Clinical response of impetigo at follow up visit. Impetigo lesion area at end of therapy and follow up visits.
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 2016.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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
22 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SB-275833 ointment, 1% in people with Impetigo, run by GlaxoSmithKline at 22 sites in 5 countries.
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 2 inclusion and 2 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 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Netherlands, India, Mexico, Peru, Italy. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinical response of impetigo at end of therapy visit. Clinical response of success is defined as no further need for antibacterial treatment.. 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 2016.