Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00133874 |
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 |
Drug: SB-275833 ointment, 1% |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Factorial Assignment, Safety/Efficacy Study |
Official Title: | See Detailed Description |
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) |
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.
Ages Eligible for Study: | 9 Months and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion Criteria:
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | TOC100224 |
Study First Received: | August 22, 2005 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00133874 |
Health Authority: | France: Afssaps - French Health Products Safety Agency; Netherlands: Medicines Evaluation Board (MEB); Italy: The Italian Medicines Agency; Germany: Federal Institute for Drugs and Medical Devices; Poland: Drug Institute; India: Ministry of Health; South Africa: Medicines Control Council; Peru: General Directorate of Pharmaceuticals, Devices, and Drugs; Mexico: National Institute of Public Health, Health Secretariat; Canada: Health Canada |
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 |