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

NCT ID: NCT00133848

Last Updated: 2016-09-23

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

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-01-31

Brief Summary

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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

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Conditions

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Impetigo

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

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

Bangalore, , India

Site Status

GSK Investigational Site

Hyderabad, , India

Site Status

GSK Investigational Site

Rome, Lazio, Italy

Site Status

GSK Investigational Site

Zapopan, Jalisco, Jalisco, Mexico

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GSK Investigational Site

Mexico City, , Mexico

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GSK Investigational Site

Beek en Donk, , Netherlands

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GSK Investigational Site

Deurne, , Netherlands

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GSK Investigational Site

Ermelo, , Netherlands

Site Status

GSK Investigational Site

Gouda, , Netherlands

Site Status

GSK Investigational Site

Musselkanaal, , Netherlands

Site Status

GSK Investigational Site

Musselkanaal, , Netherlands

Site Status

GSK Investigational Site

Nijmegen, , Netherlands

Site Status

GSK Investigational Site

Nijverdal, , Netherlands

Site Status

GSK Investigational Site

Roelofarendsveen, , Netherlands

Site Status

GSK Investigational Site

Rotterdam, , Netherlands

Site Status

GSK Investigational Site

Rotterdam, , Netherlands

Site Status

GSK Investigational Site

Soerendonk, , Netherlands

Site Status

GSK Investigational Site

Woerden, , Netherlands

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GSK Investigational Site

Zieuwent, , Netherlands

Site Status

GSK Investigational Site

Zwijndrecht, , Netherlands

Site Status

GSK Investigational Site

Callao, Provincia Constitucional del Callao, Peru

Site Status

GSK Investigational Site

Lima, , Peru

Site Status

Countries

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India Italy Mexico Netherlands Peru

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: Study Protocol

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

Document Type: Clinical Study Report

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: Informed Consent Form

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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TOC103469

Identifier Type: -

Identifier Source: org_study_id

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