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

Primary Purpose

Skin Infections, Bacterial

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SB-275833 ointment, 1%
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Infections, Bacterial focused on measuring topical antibacterial, topical antibiotic, impetigo

Eligibility Criteria

9 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
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  • GSK Investigational Site

Outcomes

Primary Outcome Measures

Clinical response assessed at end of therapy visit. Clinical success defined by the need for no additional antibiotic treatment.

Secondary Outcome Measures

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.

Full Information

First Posted
August 22, 2005
Last Updated
January 20, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00133874
Brief Title
Topical SB-275833 Ointment, 1% For The Treatment Of Impetigo
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Infections, Bacterial
Keywords
topical antibacterial, topical antibiotic, impetigo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
520 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SB-275833 ointment, 1%
Other Intervention Name(s)
SB-275833 ointment, 1%
Primary Outcome Measure Information:
Title
Clinical response assessed at end of therapy visit. Clinical success defined by the need for no additional antibiotic treatment.
Time Frame
7 Days
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M3
Country
Canada
Facility Name
GSK Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 0N2
Country
Canada
Facility Name
GSK Investigational Site
City
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1E 2C2
Country
Canada
Facility Name
GSK Investigational Site
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 3J1
Country
Canada
Facility Name
GSK Investigational Site
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2C 2N9
Country
Canada
Facility Name
GSK Investigational Site
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 6B4
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
Facility Name
GSK Investigational Site
City
San José
Country
Costa Rica
Facility Name
GSK Investigational Site
City
Anzin
ZIP/Postal Code
59410
Country
France
Facility Name
GSK Investigational Site
City
Bersee
ZIP/Postal Code
59235
Country
France
Facility Name
GSK Investigational Site
City
Labarth-Sur-Leze
ZIP/Postal Code
31860
Country
France
Facility Name
GSK Investigational Site
City
Martigues
ZIP/Postal Code
13500
Country
France
Facility Name
GSK Investigational Site
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
GSK Investigational Site
City
Seraincourt
ZIP/Postal Code
95450
Country
France
Facility Name
GSK Investigational Site
City
Vieux Condé
ZIP/Postal Code
59690
Country
France
Facility Name
GSK Investigational Site
City
Augsburg
State/Province
Bayern
ZIP/Postal Code
86179
Country
Germany
Facility Name
GSK Investigational Site
City
Gilching
State/Province
Bayern
ZIP/Postal Code
82205
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80801
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81241
Country
Germany
Facility Name
GSK Investigational Site
City
Mahlow
State/Province
Brandenburg
ZIP/Postal Code
15831
Country
Germany
Facility Name
GSK Investigational Site
City
Duelmen
State/Province
Niedersachsen
ZIP/Postal Code
48249
Country
Germany
Facility Name
GSK Investigational Site
City
Bad Honnef
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53604
Country
Germany
Facility Name
GSK Investigational Site
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53177
Country
Germany
Facility Name
GSK Investigational Site
City
Duesseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40472
Country
Germany
Facility Name
GSK Investigational Site
City
Gelsenkirchen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45879
Country
Germany
Facility Name
GSK Investigational Site
City
Kleve-Materborn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47533
Country
Germany
Facility Name
GSK Investigational Site
City
Koeln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50674
Country
Germany
Facility Name
GSK Investigational Site
City
Krefeld
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47798
Country
Germany
Facility Name
GSK Investigational Site
City
Muelheim
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45468
Country
Germany
Facility Name
GSK Investigational Site
City
Olpe
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
57462
Country
Germany
Facility Name
GSK Investigational Site
City
Unna
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
59423
Country
Germany
Facility Name
GSK Investigational Site
City
Wuppertal
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
42103
Country
Germany
Facility Name
GSK Investigational Site
City
Worms
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67547
Country
Germany
Facility Name
GSK Investigational Site
City
Doebeln
State/Province
Sachsen
ZIP/Postal Code
04720
Country
Germany
Facility Name
GSK Investigational Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01097
Country
Germany
Facility Name
GSK Investigational Site
City
Reichenbach
State/Province
Sachsen
ZIP/Postal Code
08468
Country
Germany
Facility Name
GSK Investigational Site
City
Schmiedeberg
State/Province
Sachsen
ZIP/Postal Code
01762
Country
Germany
Facility Name
GSK Investigational Site
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24103
Country
Germany
Facility Name
GSK Investigational Site
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24148
Country
Germany
Facility Name
GSK Investigational Site
City
Preetz
State/Province
Schleswig-Holstein
ZIP/Postal Code
24211
Country
Germany
Facility Name
GSK Investigational Site
City
Rendsburg
State/Province
Schleswig-Holstein
ZIP/Postal Code
24768
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10435
Country
Germany
Facility Name
GSK Investigational Site
City
Bangalore
ZIP/Postal Code
560002
Country
India
Facility Name
GSK Investigational Site
City
Bangalore
ZIP/Postal Code
560034
Country
India
Facility Name
GSK Investigational Site
City
Mumbai,
ZIP/Postal Code
400 008
Country
India
Facility Name
GSK Investigational Site
City
Zapopan, Jalisco
State/Province
Jalisco
ZIP/Postal Code
45190
Country
Mexico
Facility Name
GSK Investigational Site
City
Mexico city
ZIP/Postal Code
06780
Country
Mexico
Facility Name
GSK Investigational Site
City
Ermelo
ZIP/Postal Code
3851 EX
Country
Netherlands
Facility Name
GSK Investigational Site
City
Huizen
ZIP/Postal Code
1271 BB
Country
Netherlands
Facility Name
GSK Investigational Site
City
Losser
ZIP/Postal Code
7581 BV
Country
Netherlands
Facility Name
GSK Investigational Site
City
Musselkanaal
ZIP/Postal Code
9581 AJ
Country
Netherlands
Facility Name
GSK Investigational Site
City
Oude Pekela
ZIP/Postal Code
9665 AR
Country
Netherlands
Facility Name
GSK Investigational Site
City
Sittard
ZIP/Postal Code
6131 BK
Country
Netherlands
Facility Name
GSK Investigational Site
City
Soerendonk
ZIP/Postal Code
6027 RN
Country
Netherlands
Facility Name
GSK Investigational Site
City
Zieuwent
ZIP/Postal Code
7136 KH
Country
Netherlands
Facility Name
GSK Investigational Site
City
Zwijndrecht
ZIP/Postal Code
3331 LZ
Country
Netherlands
Facility Name
GSK Investigational Site
City
Brena
ZIP/Postal Code
Lima 5
Country
Peru
Facility Name
GSK Investigational Site
City
Grudziadz
ZIP/Postal Code
86-300
Country
Poland
Facility Name
GSK Investigational Site
City
Katowice
ZIP/Postal Code
40-027
Country
Poland
Facility Name
GSK Investigational Site
City
Poznan
ZIP/Postal Code
60-355
Country
Poland
Facility Name
GSK Investigational Site
City
Wroclaw
ZIP/Postal Code
50-368
Country
Poland
Facility Name
GSK Investigational Site
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
GSK Investigational Site
City
Cape Town
ZIP/Postal Code
7460
Country
South Africa
Facility Name
GSK Investigational Site
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
GSK Investigational Site
City
Daveyton
ZIP/Postal Code
1520
Country
South Africa
Facility Name
GSK Investigational Site
City
Eloffsdal, Pretoria
ZIP/Postal Code
0084
Country
South Africa
Facility Name
GSK Investigational Site
City
Newtown
ZIP/Postal Code
2113
Country
South Africa
Facility Name
GSK Investigational Site
City
Pretoia
ZIP/Postal Code
0084
Country
South Africa
Facility Name
GSK Investigational Site
City
Pretoria
ZIP/Postal Code
0001
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
TOC100224
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
TOC100224
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
TOC100224
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
TOC100224
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
TOC100224
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
TOC100224
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
TOC100224
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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