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
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: NCT00133874

  Show 51 Study Locations
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
Gram-Positive Bacterial Infections
Infection
Skin Diseases
Skin Diseases, Bacterial
Staphylococcal Infections
Staphylococcal Skin Infections
Streptococcal Infections

ClinicalTrials.gov processed this record on October 23, 2014