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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00133848 |
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.
Condition | Intervention | Phase |
---|---|---|
Impetigo |
Drug: SB-275833 ointment, 1% |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Factorial Assignment, Safety/Efficacy 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. |
Estimated Enrollment: | 210 |
Study Start Date: | April 2005 |
Ages Eligible for Study: | 9 Months and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion Criteria:
India | |
GSK Investigational Site | |
Bangalore, India, 560 054 | |
Italy, Lazio | |
GSK Investigational Site | |
Roma, Lazio, Italy, 00133 | |
Mexico | |
GSK Investigational Site | |
Mexico city, Mexico, 06780 | |
Mexico, Jalisco | |
GSK Investigational Site | |
Zapopan, Jalisco, Jalisco, Mexico, 45190 | |
Netherlands | |
GSK Investigational Site | |
MUSSELKANAAL, Netherlands, 9581 AJ | |
GSK Investigational Site | |
DEURNE, Netherlands, 5751 XJ | |
GSK Investigational Site | |
ZWIJNDRECHT, Netherlands, 3331 LZ | |
GSK Investigational Site | |
ERMELO, Netherlands, 3851 EX | |
GSK Investigational Site | |
Zieuwent, Netherlands, 7136 KH | |
GSK Investigational Site | |
SOERENDONK, Netherlands, 6027 RN | |
GSK Investigational Site | |
BEEK EN DONK, Netherlands, 5741 CG | |
GSK Investigational Site | |
ROTTERDAM, Netherlands, 3082 DC | |
GSK Investigational Site | |
NIJVERDAL, Netherlands, 7442 LS | |
GSK Investigational Site | |
WOERDEN, Netherlands, 3443 GG | |
GSK Investigational Site | |
ROELOFARENDSVEEN, Netherlands, 2371 RB | |
GSK Investigational Site | |
NIJMEGEN, Netherlands, 6531 NB | |
GSK Investigational Site | |
GOUDA, Netherlands, 2806 DA | |
GSK Investigational Site | |
MUSSELKANAAL, Netherlands, 9581 AD | |
GSK Investigational Site | |
ROTTERDAM, Netherlands, 3015 GE | |
Peru | |
GSK Investigational Site | |
Callao, Peru, Callao 1 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | TOC103469 |
Study First Received: | August 22, 2005 |
Last Updated: | October 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00133848 |
Health Authority: | Netherlands: Medicines Evaluation Board (MEB); Italy: The Italian Medicines Agency; India: Ministry of Health; Peru: General Directorate of Pharmaceuticals, Devices, and Drugs; Mexico: Ministry of Health |
impetigo topical antibiotic topical antibacterial |
Bacterial Infections Staphylococcal Infections Gram-Positive Bacterial Infections Skin Diseases, Infectious Skin Diseases |
Streptococcal Infections Skin Diseases, Bacterial Staphylococcal Skin Infections Impetigo |
Infection |