Skin Infections, BacterialPhase 3NCT00133874
Topical SB-275833 Ointment, 1% For The Treatment Of Impetigo
A Phase 3 study testing SB-275833 ointment, 1% in people with Skin Infections, Bacterial, run by GlaxoSmithKline at 69 sites in 10 countries.
Trial summary
The goal of this study is to determine if topical SB-275833 ointment, 1% is as safe and effective as topical sodium fusidate ointment, 2% for the treatment of impetigo in adults and children as young as 9 months of age. 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?
- SB-275833 ointment, 1%
- How many people
- 520 participants
- Where
- 69 sitesin 10 countries
- Study dates
- Apr 2005to Sep 2005
- 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
69 sites in 10 countries.
69 sites in 10 countries
Germany27 sites
GSK Investigational Site
Augsburg, Bavaria, 86179
GSK Investigational Site
Bad Honnef, North Rhine-Westphalia, 53604
GSK Investigational Site
Berlin, State of Berlin, 10435
GSK Investigational Site
Bonn, North Rhine-Westphalia, 53177
GSK Investigational Site
Cologne, North Rhine-Westphalia, 50674
GSK Investigational Site
Döbeln, Saxony, 04720
GSK Investigational Site
Dresden, Saxony, 01097
GSK Investigational Site
Duelmen, Lower Saxony, 48249
GSK Investigational Site
Düsseldorf, North Rhine-Westphalia, 40472
GSK Investigational Site
Gelsenkirchen, North Rhine-Westphalia, 45879
GSK Investigational Site
Gilching, Bavaria, 82205
GSK Investigational Site
Kiel, Schleswig-Holstein, 24103
GSK Investigational Site
Kiel, Schleswig-Holstein, 24148
GSK Investigational Site
Kleve-Materborn, North Rhine-Westphalia, 47533
GSK Investigational Site
Krefeld, North Rhine-Westphalia, 47798
GSK Investigational Site
Mahlow, Brandenburg, 15831
GSK Investigational Site
Mülheim, North Rhine-Westphalia, 45468
GSK Investigational Site
Munich, Bavaria, 80801
GSK Investigational Site
Munich, Bavaria, 81241
GSK Investigational Site
Olpe, North Rhine-Westphalia, 57462
GSK Investigational Site
Preetz, Schleswig-Holstein, 24211
GSK Investigational Site
Reichenbach, Saxony, 08468
GSK Investigational Site
Rendsburg, Schleswig-Holstein, 24768
GSK Investigational Site
Schmiedeberg, Saxony, 01762
GSK Investigational Site
Unna, North Rhine-Westphalia, 59423
GSK Investigational Site
Worms, Rhineland-Palatinate, 67547
GSK Investigational Site
Wuppertal, North Rhine-Westphalia, 42103
Netherlands9 sites
GSK Investigational Site
Ermelo, 3851 EX
GSK Investigational Site
Huizen, 1271 BB
GSK Investigational Site
Losser, 7581 BV
GSK Investigational Site
Musselkanaal, 9581 AJ
GSK Investigational Site
Oude Pekela, 9665 AR
GSK Investigational Site
Sittard, 6131 BK
GSK Investigational Site
Soerendonk, 6027 RN
GSK Investigational Site
Zieuwent, 7136 KH
GSK Investigational Site
Zwijndrecht, 3331 LZ
Canada7 sites
GSK Investigational Site
Brampton, Ontario, L6T 3J1
GSK Investigational Site
Greater Sudbury, Ontario, P3E 6B4
GSK Investigational Site
Kitchener, Ontario, N2C 2N9
GSK Investigational Site
St. John's, Newfoundland and Labrador, A1E 2C2
GSK Investigational Site
Toronto, Ontario, M9W 4L6
GSK Investigational Site
Winnipeg, Manitoba, R3A 1M3
GSK Investigational Site
Winnipeg, Manitoba, R3C 0N2
France7 sites
GSK Investigational Site
Anzin, 59410
GSK Investigational Site
Bersée, 59235
GSK Investigational Site
Labarth-Sur-Leze, 31860
GSK Investigational Site
Martigues, 13500
GSK Investigational Site
Paris, 75020
GSK Investigational Site
Seraincourt, 95450
GSK Investigational Site
Vieux-Condé, 59690
South Africa7 sites
GSK Investigational Site
Cape Town, 7460
GSK Investigational Site
Cape Town, 7925
GSK Investigational Site
Daveyton, 1520
GSK Investigational Site
Eloffsdal, Pretoria, 0084
GSK Investigational Site
Newtown, 2113
GSK Investigational Site
Pretoia, 0084
GSK Investigational Site
Pretoria, 0001
Poland5 sites
GSK Investigational Site
Grudziądz, 86-300
GSK Investigational Site
Katowice, 40-027
GSK Investigational Site
Poznan, 60-355
GSK Investigational Site
Wroclaw, 50-368
GSK Investigational Site
Zabrze, 41-800
India3 sites
GSK Investigational Site
Bangalore, 560002
GSK Investigational Site
Bangalore, 560034
GSK Investigational Site
Mumbai, 400 008
Mexico2 sites
GSK Investigational Site
Mexico City, 06780
GSK Investigational Site
Zapopan, Jalisco, Jalisco, 45190
About this study
Official title: An Observer-blind, Multicenter, Non-inferiority, Comparative Study of the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily for 5 Days, Versus Topical 2% Fusidic Acid Cream Applied Three Times Daily for 7 Days in the Treatment Adult and Paediatric Subjects With Impetigo
The goal of this study is to determine if topical SB-275833 ointment, 1% is as safe and effective as topical sodium fusidate ointment, 2% for the treatment of impetigo in adults and children as young as 9 months of age.
Read the detailed description
A Randomised, Observer-blind, Multicentre, Non-inferiority, Comparative, Phase III Study of the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily for 5 Days, versus Topical 2% Sodium Fusidate Ointment Applied Three Times Daily for 7 Days in the Treatment of Adult and Paediatric Subjects with Impetigo.
- Conditions
- Skin Infections, Bacterial
- Being tested
- SB-275833 ointment, 1%
- Keywords
- topical antibacterial, topical antibiotic, impetigo
- Medical subject headings
- Cellulitis, 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 assessed at end of therapy visit. Clinical success defined by the need for no additional antibiotic treatment.
Measured: 7 Days
Secondary outcomes (1)
Clinical response assessed at follow up visit. Microbiologic response at end of therapy and follow up visits. Impetigo lesion area measured at end of therapy and follow up visits.
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 posted24 Aug 2005 (estimated)
- Study startApr 2005
- Primary completionSep 2005
- Study completionSep 2005
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 520 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
- NCT00133874
- Sponsor's protocol ID
- TOC100224
- Status last verified
- Jan 2017
- First submitted
- 22 Aug 2005
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- 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 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observer-blind, Multicenter, Non-inferiority, Comparative Study of the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily for 5 Days, Versus Topical 2% Fusidic Acid Cream Applied Three Times Daily for 7 Days in the Treatment Adult and Paediatric Subjects With Impetigo
- ClinicalTrials.gov ID
- NCT00133874
- Acronym / sponsor ID
- TOC100224
- Conditions
- Skin Infections, Bacterial
- Keywords
- topical antibacterial, topical antibiotic, impetigo
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (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 as safe and effective as topical sodium fusidate ointment, 2% for the treatment of impetigo in adults and children as young as 9 months of age.
Detailed description
A Randomised, Observer-blind, Multicentre, Non-inferiority, Comparative, Phase III Study of the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily for 5 Days, versus Topical 2% Sodium Fusidate Ointment Applied Three Times Daily for 7 Days in the Treatment of Adult and Paediatric Subjects with Impetigo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
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 assessed at end of therapy visit. Clinical success defined by the need for no additional antibiotic treatment.
Time frame: 7 Days
1 secondary outcome
Clinical response assessed at follow up visit. Microbiologic response at end of therapy and follow up visits. Impetigo lesion area measured at end of therapy and follow up visits.
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 Jan 2017.
- 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
69 sites in 10 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 Skin Infections, Bacterial, run by GlaxoSmithKline at 69 sites in 10 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 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in Germany, Netherlands, Canada, France, South Africa and 5 more countries. 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 assessed at end of therapy visit. Clinical success defined by the need for no additional antibiotic treatment. (time frame: 7 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 Jan 2017.