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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-004406-24-IT
Enrollment
210
Registered
2007-02-02
Start date
2005-07-26
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of the impetigo MedDRA version: 6.1 Level: PT Classification code 10021531

Interventions

Trade Name: D06AX-altri antibiotici per uso topico Product Name: PLEUROMUTILIN Product Code: SB 275833 Pharmaceutical Form: Ointment Current Sponsor code: SB 275833 Concentration unit: mg milligram(s)

Sponsors

GLAXO SMITHKLINE
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Main Objective: ;Secondary Objective: ;Primary end point(s):

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026