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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00133848
First received: August 22, 2005
Last updated: September 22, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention Phase
Impetigo
Drug: SB-275833 ointment, 1%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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.

Estimated Enrollment: 210
Study Start Date: April 2005
Study Completion Date: January 2006
Intervention Details:
    Drug: SB-275833 ointment, 1%
    Other Names:
    • SB-275833 ointment
    • 1%
  Eligibility

Ages Eligible for Study:   9 Months and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133848

Locations
India
GSK Investigational Site
Bangalore, India, 560 054
GSK Investigational Site
Hyderabad, India, 40000
Italy
GSK Investigational Site
Roma, Lazio, Italy, 00133
Mexico
GSK Investigational Site
Zapopan, Jalisco, Jalisco, Mexico, 45190
GSK Investigational Site
Mexico city, Mexico, 06780
Netherlands
GSK Investigational Site
Beek En Donk, Netherlands, 5741 CG
GSK Investigational Site
Deurne, Netherlands, 5751 XJ
GSK Investigational Site
Ermelo, Netherlands, 3851 EX
GSK Investigational Site
Gouda, Netherlands, 2806 DA
GSK Investigational Site
Musselkanaal, Netherlands, 9581 AD
GSK Investigational Site
Musselkanaal, Netherlands, 9581 AJ
GSK Investigational Site
Nijmegen, Netherlands, 6531 NB
GSK Investigational Site
Nijverdal, Netherlands, 7442 LS
GSK Investigational Site
Roelofarendsveen, Netherlands, 2371 RB
GSK Investigational Site
Rotterdam, Netherlands, 3015 GE
GSK Investigational Site
Rotterdam, Netherlands, 3082 DC
GSK Investigational Site
Soerendonk, Netherlands, 6027 RN
GSK Investigational Site
Woerden, Netherlands, 3443 GG
GSK Investigational Site
Zieuwent, Netherlands, 7136 KH
GSK Investigational Site
Zwijndrecht, Netherlands, 3331 LZ
Peru
GSK Investigational Site
Callao, Peru, Callao 1
GSK Investigational Site
Lima, Peru, Lima 31
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: TOC103469
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: TOC103469
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: TOC103469
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: TOC103469
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: TOC103469
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: TOC103469
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: TOC103469
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00133848     History of Changes
Other Study ID Numbers: TOC103469 
Study First Received: August 22, 2005
Last Updated: September 22, 2016
Health Authority: India: Ministry of Health
Italy: The Italian Medicines Agency
Mexico: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Individual Participant Data  
Plan to Share IPD: Yes
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.

Keywords provided by GlaxoSmithKline:
impetigo
topical antibacterial
topical antibiotic

Additional relevant MeSH terms:
Impetigo
Staphylococcal Skin Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Streptococcal Infections
Skin Diseases, Bacterial
Skin Diseases, Infectious
Infection
Skin Diseases

ClinicalTrials.gov processed this record on December 09, 2016