Topical SB-275833 Ointment, 1% For The Treatment Of Impetigo

NCT ID: NCT00133874

Last Updated: 2017-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

520 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2005-09-30

Brief Summary

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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

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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

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Skin Infections, Bacterial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Interventions

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SB-275833 ointment, 1%

Intervention Type DRUG

Other Intervention Names

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SB-275833 ointment 1%

Eligibility Criteria

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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.
Minimum Eligible Age

9 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Winnipeg, Manitoba, Canada

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Winnipeg, Manitoba, Canada

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St. John's, Newfoundland and Labrador, Canada

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Brampton, Ontario, Canada

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Greater Sudbury, Ontario, Canada

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Kitchener, Ontario, Canada

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Toronto, Ontario, Canada

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San José, , Costa Rica

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Anzin, , France

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Bersée, , France

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Labarth-Sur-Leze, , France

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Martigues, , France

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Paris, , France

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Seraincourt, , France

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Vieux-Condé, , France

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Augsburg, Bavaria, Germany

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Gilching, Bavaria, Germany

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Munich, Bavaria, Germany

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Munich, Bavaria, Germany

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Mahlow, Brandenburg, Germany

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Duelmen, Lower Saxony, Germany

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Bad Honnef, North Rhine-Westphalia, Germany

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Bonn, North Rhine-Westphalia, Germany

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Cologne, North Rhine-Westphalia, Germany

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Düsseldorf, North Rhine-Westphalia, Germany

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Gelsenkirchen, North Rhine-Westphalia, Germany

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Kleve-Materborn, North Rhine-Westphalia, Germany

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Krefeld, North Rhine-Westphalia, Germany

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Mülheim, North Rhine-Westphalia, Germany

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Olpe, North Rhine-Westphalia, Germany

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Unna, North Rhine-Westphalia, Germany

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Wuppertal, North Rhine-Westphalia, Germany

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Worms, Rhineland-Palatinate, Germany

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Döbeln, Saxony, Germany

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Dresden, Saxony, Germany

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Reichenbach, Saxony, Germany

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Schmiedeberg, Saxony, Germany

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Kiel, Schleswig-Holstein, Germany

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Kiel, Schleswig-Holstein, Germany

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Preetz, Schleswig-Holstein, Germany

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Rendsburg, Schleswig-Holstein, Germany

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Berlin, State of Berlin, Germany

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Bangalore, , India

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Bangalore, , India

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Mumbai, , India

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Zapopan, Jalisco, Jalisco, Mexico

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Mexico City, , Mexico

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Ermelo, , Netherlands

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Huizen, , Netherlands

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Losser, , Netherlands

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Musselkanaal, , Netherlands

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Oude Pekela, , Netherlands

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Sittard, , Netherlands

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Soerendonk, , Netherlands

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Zieuwent, , Netherlands

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Zwijndrecht, , Netherlands

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Breña, , Peru

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Grudziądz, , Poland

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Katowice, , Poland

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Poznan, , Poland

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Wroclaw, , Poland

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Zabrze, , Poland

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Cape Town, , South Africa

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Cape Town, , South Africa

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Daveyton, , South Africa

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Eloffsdal, Pretoria, , South Africa

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Newtown, , South Africa

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Pretoia, , South Africa

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Pretoria, , South Africa

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Countries

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Canada Costa Rica France Germany India Mexico Netherlands Peru Poland South Africa

Study Documents

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Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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TOC100224

Identifier Type: -

Identifier Source: org_study_id

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