Retapamulin Versus Placebo in Secondarily-Infected Traumatic Lesions - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00684177

Purpose

The purpose of Study TOC110977 is to demonstrate clinical superiority of Retapamulin ointment, 1%, over placebo in patients with secondarily-infected traumatic lesions, which includes secondarily-infected lacerations, abrasions and sutured wounds. Subjects 2 months of age and older will be treated with topical retapamulin or placebo ointment twice daily for 5 days. The primary endpoint of this study is the clinical response at follow-up (Day 12-14; 7-9 days after the end of therapy) in the intent-to-treat clinical population.

Condition	Intervention	Phase
Secondarily-Infected Traumatic Lesions Including Secondarily-Infected Lacerations Sutured Wounds and Abrasions	Drug: Retapamulin Ointment, 1%	Phase III

Drug Information available for: Retapamulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
Official Title:	See Detailed Description

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Clinical response at follow-up (Day 12-14)in the intent-to-treat clinical population.

Secondary Outcome Measures:

Clinical response at end of therapy (Day 7-9) Microbiological response at follow-up Microbiological response at end of therapy Therapeutic response at follow-up

Estimated Enrollment:	357
Study Start Date:	May 2008

Detailed Description:

A Randomized, Double-Blind, Multicenter, Placebo-controlled, Phase III Superiority Study to Assess the Safety and Efficacy of Topical Retapamulin Ointment, 1%, versus Placebo Ointment Applied Twice Daily for 5 Days in the Treatment of Adult and Pediatric Subjects with Secondarily-Infected Traumatic Lesions

Eligibility

Ages Eligible for Study:	2 Months and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

subject is aged 2 months or older
subject has secondarily-infected traumatic lesion (laceration, sutured wound or abrasion)
negative urine pregnancy test
subject has total skin infection rating scale score of at least 8, including pus/exudate scor of at least 1
subject and/or parent/legal guardian is willing and able to comply with protocol
subject or parent/legal guardian has given written informed consent or assent as applicable

Exclusion criteria:

previous hypersensitivity to pleuromutilin
secondarily-infected animal/human bite or puncture wound
subject has an abscess
chronic ulcerative lesion
underlying skin disease
systemic signs and symptoms of infection
infection not appropriately treated with topical antibiotic
infection requires surgical intervention
subject received systemic antibacterial or steroid, or topical therapeutic agent within 24 hours of entry into study
serious underlying disease
subject pregnant, breast feeding or planning a pregnancy, or unacceptable method of contraception
other investigational drug within 30 days of study entry
subject previously enrolled in this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00684177

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Show 106 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	TOC110977
Study First Received:	May 22, 2008
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00684177
Health Authority:	United States: Food and Drug Administration; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

retapamulin
placebo
secondarily-infected traumatic lesions
infection

Study placed in the following topic categories:

Lacerations
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on January 16, 2009