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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00133874
First received: August 22, 2005
Last updated: May 31, 2012
Last verified: March 2011
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Single Blind
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 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. [ Time Frame: 7 Days ]

Estimated Enrollment: 520
Study Start Date: April 2005
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: SB-275833 ointment, 1%
    Other Names:
    • SB-275833 ointment
    • 1%
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.

  Eligibility

Ages Eligible for Study:   9 Months and older
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00133874

  Hide Study Locations
Locations
Canada, Manitoba
GSK Investigational Site
Winnipeg, Manitoba, Canada, R3C 0N2
GSK Investigational Site
Winnipeg, Manitoba, Canada, R3A 1M3
Canada, Newfoundland and Labrador
GSK Investigational Site
Saint John's, Newfoundland and Labrador, Canada, A1E 2C2
Canada, Ontario
GSK Investigational Site
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
Costa Rica
GSK Investigational Site
San José, Costa Rica
France
GSK Investigational Site
Bersee, France, 59235
GSK Investigational Site
Martigues, France, 13500
GSK Investigational Site
Paris, France, 75020
GSK Investigational Site
Vieux Condé, France, 59690
Germany
GSK Investigational Site
Augsburg, Bayern, Germany, 86179
GSK Investigational Site
Mahlow, Brandenburg, Germany, 15831
GSK Investigational Site
Duelmen, Niedersachsen, Germany, 48249
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
Unna, Nordrhein-Westfalen, Germany, 59423
GSK Investigational Site
Worms, Rheinland-Pfalz, Germany, 67547
GSK Investigational Site
Schmiedeberg, Sachsen, Germany, 01762
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24103
GSK Investigational Site
Preetz, Schleswig-Holstein, Germany, 24211
GSK Investigational Site
Rendsburg, Schleswig-Holstein, Germany, 24768
GSK Investigational Site
Berlin, Germany, 10435
India
GSK Investigational Site
Bangalore, India, 560002
GSK Investigational Site
Bangalore, India, 560034
GSK Investigational Site
Mumbai, India, 400 008
Netherlands
GSK Investigational Site
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
Peru
GSK Investigational Site
Brena, Peru, Lima 5
Poland
GSK Investigational Site
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
South Africa
GSK Investigational Site
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
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00133874     History of Changes
Other Study ID Numbers: TOC100224
Study First Received: August 22, 2005
Last Updated: May 31, 2012
Health Authority: Mexico: National Institute of Public Health, Health Secretariat
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
South Africa: Medicines Control Council
India: Ministry of Health
Canada: Health Canada
Italy: The Italian Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs

Keywords provided by GlaxoSmithKline:
topical antibacterial
topical antibiotic
impetigo

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

ClinicalTrials.gov processed this record on April 23, 2014