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

Primary Purpose

Impetigo

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 Impetigo focused on measuring impetigo, topical antibacterial, topical antibiotic

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 22, 2005
Last Updated
September 22, 2016
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00133848
Brief Title
Treatment Of Impetigo With Topical SB-275833 Ointment, 1% Versus Topical Placebo Ointment
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
Enrollment
210 (false)

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 of impetigo at end of therapy visit. Clinical response of success is defined as no further need for antibacterial treatment.
Secondary Outcome Measure Information:
Title
Clinical response of impetigo at follow up visit. Impetigo lesion area at end of therapy and follow up visits.

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
Bangalore
ZIP/Postal Code
560 054
Country
India
Facility Name
GSK Investigational Site
City
Hyderabad
ZIP/Postal Code
40000
Country
India
Facility Name
GSK Investigational Site
City
Roma
State/Province
Lazio
ZIP/Postal Code
00133
Country
Italy
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
Beek En Donk
ZIP/Postal Code
5741 CG
Country
Netherlands
Facility Name
GSK Investigational Site
City
Deurne
ZIP/Postal Code
5751 XJ
Country
Netherlands
Facility Name
GSK Investigational Site
City
Ermelo
ZIP/Postal Code
3851 EX
Country
Netherlands
Facility Name
GSK Investigational Site
City
Gouda
ZIP/Postal Code
2806 DA
Country
Netherlands
Facility Name
GSK Investigational Site
City
Musselkanaal
ZIP/Postal Code
9581 AD
Country
Netherlands
Facility Name
GSK Investigational Site
City
Musselkanaal
ZIP/Postal Code
9581 AJ
Country
Netherlands
Facility Name
GSK Investigational Site
City
Nijmegen
ZIP/Postal Code
6531 NB
Country
Netherlands
Facility Name
GSK Investigational Site
City
Nijverdal
ZIP/Postal Code
7442 LS
Country
Netherlands
Facility Name
GSK Investigational Site
City
Roelofarendsveen
ZIP/Postal Code
2371 RB
Country
Netherlands
Facility Name
GSK Investigational Site
City
Rotterdam
ZIP/Postal Code
3015 GE
Country
Netherlands
Facility Name
GSK Investigational Site
City
Rotterdam
ZIP/Postal Code
3082 DC
Country
Netherlands
Facility Name
GSK Investigational Site
City
Soerendonk
ZIP/Postal Code
6027 RN
Country
Netherlands
Facility Name
GSK Investigational Site
City
Woerden
ZIP/Postal Code
3443 GG
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
Callao
ZIP/Postal Code
Callao 1
Country
Peru
Facility Name
GSK Investigational Site
City
Lima
ZIP/Postal Code
Lima 31
Country
Peru

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
TOC103469
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
TOC103469
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
TOC103469
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
TOC103469
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
TOC103469
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
TOC103469
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
TOC103469
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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