Treatment Of Impetigo With Topical SB-275833 Ointment, 1% Versus Topical Placebo Ointment - Tabular View

Tracking Information

First Received Date ^ICMJE

August 22, 2005

Last Updated Date

May 15, 2009

Start Date ^ICMJE

April 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Clinical response of impetigo at end of therapy visit. Clinical response of success is defined as no further need for antibacterial treatment.

Original Primary Outcome Measures ^ICMJE

Clinical response of impetigo at end of therapy visit. Clinical response of success is defined as no further need for antibacterial treatment.

Change History

Complete list of historical versions of study NCT00133848 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Clinical response of impetigo at follow up visit. Impetigo lesion area at end of therapy and follow up visits.

Original Secondary Outcome Measures ^ICMJE

Clinical response of impetigo at follow up visit. Impetigo lesion area at end of therapy and follow up visits.

Descriptive Information

Brief Title ^ICMJE

Treatment Of Impetigo With Topical SB-275833 Ointment, 1% Versus Topical Placebo Ointment

Official Title ^ICMJE

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.

Brief 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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Factorial Assignment, Safety/Efficacy Study

Condition ^ICMJE

Impetigo

Intervention ^ICMJE

Drug: SB-275833 ointment, 1%

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

210

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

9 Months and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

India, Italy, Mexico, Netherlands, Peru

Administrative Information

NCT ID ^ICMJE

NCT00133848

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

TOC103469

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP