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

January 20, 2017 updated by: GlaxoSmithKline

An Observer-blind, Multicenter, Non-inferiority, Comparative Study of the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily for 5 Days, Versus Topical 2% Fusidic Acid Cream Applied Three Times Daily for 7 Days in the Treatment Adult and Paediatric Subjects With Impetigo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

520

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C 0N2
        • GSK Investigational Site
      • Winnipeg, Manitoba, Canada, R3A 1M3
        • GSK Investigational Site
    • Newfoundland and Labrador
      • Saint John's, Newfoundland and Labrador, Canada, A1E 2C2
        • GSK Investigational Site
    • Ontario
      • Brampton, Ontario, Canada, L6T 3J1
        • GSK Investigational Site
      • Kitchener, Ontario, Canada, N2C 2N9
        • GSK Investigational Site
      • Sudbury, Ontario, Canada, P3E 6B4
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M9W 4L6
        • GSK Investigational Site
  • Costa Rica
      • San José, Costa Rica
        • GSK Investigational Site
  • France
      • Anzin, France, 59410
        • GSK Investigational Site
      • Bersee, France, 59235
        • GSK Investigational Site
      • Labarth-Sur-Leze, France, 31860
        • GSK Investigational Site
      • Martigues, France, 13500
        • GSK Investigational Site
      • Paris, France, 75020
        • GSK Investigational Site
      • Seraincourt, France, 95450
        • GSK Investigational Site
      • Vieux Condé, France, 59690
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 10435
        • GSK Investigational Site
    • Bayern
      • Augsburg, Bayern, Germany, 86179
        • GSK Investigational Site
      • Gilching, Bayern, Germany, 82205
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81241
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 80801
        • GSK Investigational Site
    • Brandenburg
      • Mahlow, Brandenburg, Germany, 15831
        • GSK Investigational Site
    • Niedersachsen
      • Duelmen, Niedersachsen, Germany, 48249
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Bad Honnef, Nordrhein-Westfalen, Germany, 53604
        • GSK Investigational Site
      • Bonn, Nordrhein-Westfalen, Germany, 53177
        • GSK Investigational Site
      • Duesseldorf, Nordrhein-Westfalen, Germany, 40472
        • GSK Investigational Site
      • Gelsenkirchen, Nordrhein-Westfalen, Germany, 45879
        • GSK Investigational Site
      • Kleve-Materborn, Nordrhein-Westfalen, Germany, 47533
        • GSK Investigational Site
      • Koeln, Nordrhein-Westfalen, Germany, 50674
        • GSK Investigational Site
      • Krefeld, Nordrhein-Westfalen, Germany, 47798
        • GSK Investigational Site
      • Muelheim, Nordrhein-Westfalen, Germany, 45468
        • GSK Investigational Site
      • Olpe, Nordrhein-Westfalen, Germany, 57462
        • GSK Investigational Site
      • Unna, Nordrhein-Westfalen, Germany, 59423
        • GSK Investigational Site
      • Wuppertal, Nordrhein-Westfalen, Germany, 42103
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Worms, Rheinland-Pfalz, Germany, 67547
        • GSK Investigational Site
    • Sachsen
      • Doebeln, Sachsen, Germany, 04720
        • GSK Investigational Site
      • Dresden, Sachsen, Germany, 01097
        • GSK Investigational Site
      • Reichenbach, Sachsen, Germany, 08468
        • GSK Investigational Site
      • Schmiedeberg, Sachsen, Germany, 01762
        • GSK Investigational Site
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24103
        • GSK Investigational Site
      • Kiel, Schleswig-Holstein, Germany, 24148
        • GSK Investigational Site
      • Preetz, Schleswig-Holstein, Germany, 24211
        • GSK Investigational Site
      • Rendsburg, Schleswig-Holstein, Germany, 24768
        • GSK Investigational Site
  • India
      • Bangalore, India, 560034
        • GSK Investigational Site
      • Bangalore, India, 560002
        • GSK Investigational Site
      • Mumbai,, India, 400 008
        • GSK Investigational Site
  • Mexico
      • Mexico city, Mexico, 06780
        • GSK Investigational Site
    • Jalisco
      • Zapopan, Jalisco, Jalisco, Mexico, 45190
        • GSK Investigational Site
  • Netherlands
      • Ermelo, Netherlands, 3851 EX
        • GSK Investigational Site
      • Huizen, Netherlands, 1271 BB
        • GSK Investigational Site
      • Losser, Netherlands, 7581 BV
        • GSK Investigational Site
      • Musselkanaal, Netherlands, 9581 AJ
        • GSK Investigational Site
      • Oude Pekela, Netherlands, 9665 AR
        • GSK Investigational Site
      • Sittard, Netherlands, 6131 BK
        • GSK Investigational Site
      • Soerendonk, Netherlands, 6027 RN
        • GSK Investigational Site
      • Zieuwent, Netherlands, 7136 KH
        • GSK Investigational Site
      • Zwijndrecht, Netherlands, 3331 LZ
        • GSK Investigational Site
  • Peru
      • Brena, Peru, Lima 5
        • GSK Investigational Site
  • Poland
      • Grudziadz, Poland, 86-300
        • GSK Investigational Site
      • Katowice, Poland, 40-027
        • GSK Investigational Site
      • Poznan, Poland, 60-355
        • GSK Investigational Site
      • Wroclaw, Poland, 50-368
        • GSK Investigational Site
      • Zabrze, Poland, 41-800
        • GSK Investigational Site
  • South Africa
      • Cape Town, South Africa, 7925
        • GSK Investigational Site
      • Cape Town, South Africa, 7460
        • GSK Investigational Site
      • Daveyton, South Africa, 1520
        • GSK Investigational Site
      • Eloffsdal, Pretoria, South Africa, 0084
        • GSK Investigational Site
      • Newtown, South Africa, 2113
        • GSK Investigational Site
      • Pretoia, South Africa, 0084
        • GSK Investigational Site
      • Pretoria, South Africa, 0001
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical response assessed at end of therapy visit. Clinical success defined by the need for no additional antibiotic treatment.
Time Frame: 7 Days
7 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical response assessed at follow up visit. Microbiologic response at end of therapy and follow up visits. Impetigo lesion area measured at end of therapy and follow up visits.
Time Frame: 7 Days
7 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

August 22, 2005

First Submitted That Met QC Criteria

August 23, 2005

First Posted (Estimate)

August 24, 2005

Study Record Updates

Last Update Posted (Estimate)

January 23, 2017

Last Update Submitted That Met QC Criteria

January 20, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOC100224

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Annotated Case Report Form
    Information identifier: TOC100224
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Statistical Analysis Plan
    Information identifier: TOC100224
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Dataset Specification
    Information identifier: TOC100224
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Study Protocol
    Information identifier: TOC100224
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Clinical Study Report
    Information identifier: TOC100224
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Informed Consent Form
    Information identifier: TOC100224
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Individual Participant Data Set
    Information identifier: TOC100224
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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