Topical SB-275833 Ointment, 1% For The Treatment Of Impetigo
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00133874
First received: August 22, 2005
Last updated: May 31, 2012
Last verified: March 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Impetigo Skin Infections, Bacterial |
Drug: SB-275833 ointment, 1% |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | See Detailed Description |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Clinical response assessed at end of therapy visit. Clinical success defined by the need for no additional antibiotic treatment. [ Time Frame: 7 Days ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 520 |
| Study Start Date: | April 2005 |
| Study Completion Date: | September 2005 |
| Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: SB-275833 ointment, 1%
- SB-275833 ointment
- 1%
Other Names:
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.
Eligibility| Ages Eligible for Study: | 9 Months and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- 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.
Exclusion Criteria:
- Any signs and symptoms of systemic infection.
- Any serious underlying disease that could be imminently life threatening.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00133874
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| Canada, Manitoba | |
| GSK Investigational Site | |
| Winnipeg, Manitoba, Canada, R3C 0N2 | |
| GSK Investigational Site | |
| Winnipeg, Manitoba, Canada, R3A 1M3 | |
| Canada, Newfoundland and Labrador | |
| GSK Investigational Site | |
| Saint John's, Newfoundland and Labrador, Canada, A1E 2C2 | |
| Canada, Ontario | |
| GSK Investigational Site | |
| Brampton, Ontario, Canada, L6T 3J1 | |
| GSK Investigational Site | |
| Kitchener, Ontario, Canada, N2C 2N9 | |
| GSK Investigational Site | |
| Sudbury, Ontario, Canada, P3E 6B4 | |
| GSK Investigational Site | |
| Toronto, Ontario, Canada, M9W 4L6 | |
| Costa Rica | |
| GSK Investigational Site | |
| San José, Costa Rica | |
| France | |
| GSK Investigational Site | |
| Bersee, France, 59235 | |
| GSK Investigational Site | |
| Martigues, France, 13500 | |
| GSK Investigational Site | |
| Paris, France, 75020 | |
| GSK Investigational Site | |
| Vieux Condé, France, 59690 | |
| Germany | |
| GSK Investigational Site | |
| Augsburg, Bayern, Germany, 86179 | |
| GSK Investigational Site | |
| Mahlow, Brandenburg, Germany, 15831 | |
| GSK Investigational Site | |
| Duelmen, Niedersachsen, Germany, 48249 | |
| GSK Investigational Site | |
| Duesseldorf, Nordrhein-Westfalen, Germany, 40472 | |
| GSK Investigational Site | |
| Gelsenkirchen, Nordrhein-Westfalen, Germany, 45879 | |
| GSK Investigational Site | |
| Kleve-Materborn, Nordrhein-Westfalen, Germany, 47533 | |
| GSK Investigational Site | |
| Koeln, Nordrhein-Westfalen, Germany, 50674 | |
| GSK Investigational Site | |
| Krefeld, Nordrhein-Westfalen, Germany, 47798 | |
| GSK Investigational Site | |
| Unna, Nordrhein-Westfalen, Germany, 59423 | |
| GSK Investigational Site | |
| Worms, Rheinland-Pfalz, Germany, 67547 | |
| GSK Investigational Site | |
| Schmiedeberg, Sachsen, Germany, 01762 | |
| GSK Investigational Site | |
| Kiel, Schleswig-Holstein, Germany, 24103 | |
| GSK Investigational Site | |
| Preetz, Schleswig-Holstein, Germany, 24211 | |
| GSK Investigational Site | |
| Rendsburg, Schleswig-Holstein, Germany, 24768 | |
| GSK Investigational Site | |
| Berlin, Germany, 10435 | |
| India | |
| GSK Investigational Site | |
| Bangalore, India, 560002 | |
| GSK Investigational Site | |
| Bangalore, India, 560034 | |
| GSK Investigational Site | |
| Mumbai, India, 400 008 | |
| Netherlands | |
| GSK Investigational Site | |
| Ermelo, Netherlands, 3851 EX | |
| GSK Investigational Site | |
| Huizen, Netherlands, 1271 BB | |
| GSK Investigational Site | |
| Losser, Netherlands, 7581 BV | |
| GSK Investigational Site | |
| Musselkanaal, Netherlands, 9581 AJ | |
| GSK Investigational Site | |
| Oude Pekela, Netherlands, 9665 AR | |
| GSK Investigational Site | |
| Sittard, Netherlands, 6131 BK | |
| GSK Investigational Site | |
| Soerendonk, Netherlands, 6027 RN | |
| GSK Investigational Site | |
| Zieuwent, Netherlands, 7136 KH | |
| GSK Investigational Site | |
| Zwijndrecht, Netherlands, 3331 LZ | |
| Peru | |
| GSK Investigational Site | |
| Brena, Peru, Lima 5 | |
| Poland | |
| GSK Investigational Site | |
| Grudziadz, Poland, 86-300 | |
| GSK Investigational Site | |
| Katowice, Poland, 40-027 | |
| GSK Investigational Site | |
| Poznan, Poland, 60-355 | |
| GSK Investigational Site | |
| Wroclaw, Poland, 50-368 | |
| GSK Investigational Site | |
| Zabrze, Poland, 41-800 | |
| South Africa | |
| GSK Investigational Site | |
| Cape Town, South Africa, 7925 | |
| GSK Investigational Site | |
| Cape Town, South Africa, 7460 | |
| GSK Investigational Site | |
| Daveyton, South Africa, 1520 | |
| GSK Investigational Site | |
| Eloffsdal, Pretoria, South Africa, 0084 | |
| GSK Investigational Site | |
| Newtown, South Africa, 2113 | |
| GSK Investigational Site | |
| Pretoia, South Africa, 0084 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00133874 History of Changes |
| Other Study ID Numbers: | TOC100224 |
| Study First Received: | August 22, 2005 |
| Last Updated: | May 31, 2012 |
| Health Authority: | Mexico: National Institute of Public Health, Health Secretariat France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices South Africa: Medicines Control Council India: Ministry of Health Canada: Health Canada Italy: The Italian Medicines Agency Netherlands: Medicines Evaluation Board (MEB) Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Peru: General Directorate of Pharmaceuticals, Devices, and Drugs |
Keywords provided by GlaxoSmithKline:
|
topical antibacterial topical antibiotic impetigo |
Additional relevant MeSH terms:
|
Bacterial Infections Impetigo Skin Diseases, Infectious Staphylococcal Skin Infections Staphylococcal Infections |
Gram-Positive Bacterial Infections Streptococcal Infections Skin Diseases, Bacterial Infection Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013