Last updated: 11/07/2018 19:39:02
Retapamulin Versus Placebo in Secondarily-Infected Traumatic Lesions (SITL)
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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 SITL
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Number of Participants with Clinical Success and Failure at Follow-up (7-9 days post therapy) for the Primary Efficacy Population
Timeframe: Days 12-14
Secondary outcomes:
Number of Participants with Clinical Success and Failure at Follow-up (7-9 days post therapy) for the Intent-to-Treat Bacteriology (ITTB) subset of the Primary Efficacy Population
Timeframe: Days 12-14
Number of Participants with Microbiological Success and Failure at Follow-up (7-9 days post therapy)
Timeframe: Days 12-14
Number of Participants with the Indicated Clinical Outcome at End of Therapy (2-4 days post therapy)
Timeframe: Days 7-9
Number of Baseline Pathogens with the Indicated Microbiological Outcome at End of Therapy (2-4 days post therapy)
Timeframe: Days 7-9
Number of Participants with Therapeutic Success and Failure at Follow-up (7-9 days post therapy)
Timeframe: Follow-up (Days 12-14)
Interventions:
Drug: Retapamulin Ointment, 1%
Drug: Placebo ointment
Enrollment:
508
Observational study model:
Not applicable
Primary completion date:
2009-02-10
Time perspective:
Not applicable
Clinical publications:
John F Tomayko, MD Gang Li, PhD John J Breton, PhD Nicole Scangarella-Oman, MS MaryBeth Dalessandro, BS Michael Martin, MD. The safety and efficacy of topical retapamulin ointment versus placebo ointment in the treatment of secondarily-infected traumatic lesions: A randomized, double-blind superiority study. Adv Skin Wound Care. 2013;26(3):113-126.
Medical condition
Skin Infections, Bacterial
Product
retapamulin
Collaborators
Not applicable
Study date(s)
May 2008 to October 2009
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
2+ years
Accepts healthy volunteers
No
- subject is aged 2 months or older
- subject has secondarily-infected traumatic lesion (laceration, sutured wound or abrasion)
- previous hypersensitivity to pleuromutilin
- secondarily-infected animal/human bite or puncture wound
Inclusion and exclusion 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 score of at least 3
- 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 prior to or during study
- 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
Trial location(s)
Location
GSK Investigational Site
Vienna, Virginia, United States, 22180
Status
Study Complete
Location
GSK Investigational Site
Vero Beach, Florida, United States, 32960
Status
Study Complete
Location
GSK Investigational Site
Loma Hermosa, Buenos Aires, Argentina, 1657
Status
Study Complete
Location
GSK Investigational Site
Anaheim, California, United States, 92804
Status
Study Complete
Location
GSK Investigational Site
Hollywood, Florida, United States, 33023
Status
Study Complete
Location
GSK Investigational Site
Kansas City, Kansas, United States, 66160
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Irvine, California, United States, 90620
Status
Study Complete
Location
GSK Investigational Site
Fresno, California, United States, 93710
Status
Study Complete
Location
GSK Investigational Site
Johnson City, New York, United States, 13790
Status
Study Complete
Location
GSK Investigational Site
New Orleans, Louisiana, United States, 70112
Status
Study Complete
Location
GSK Investigational Site
Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080
Status
Will Be Recruiting
Location
GSK Investigational Site
East Syracuse, New York, United States, 13057
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Curitiba/Paraná, Paraná, Brazil, 80810-050
Status
Will Be Recruiting
Location
GSK Investigational Site
West Palm Beach, Florida, United States, 33401
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80904
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, CP1431FWO
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29615
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chivilocoy, Buenos Aires, Argentina, 6620
Status
Study Complete
Location
GSK Investigational Site
Tampa, Florida, United States, 33606
Status
Will Be Recruiting
Location
GSK Investigational Site
Uniontown, Pennsylvania, United States, 15401
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Panama City, Florida, United States, 32401
Status
Will Be Recruiting
Location
GSK Investigational Site
Sacramento, California, United States, 95825
Status
Terminated/Withdrawn
Location
GSK Investigational Site
norristown, Pennsylvania, United States, 19401
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32712
Status
Will Be Recruiting
Location
GSK Investigational Site
Brooklyn, New York, United States, 11229
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Brooklyn, New York, United States, 11218
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Arlington Heights, Illinois, United States, 60005
Status
Will Be Recruiting
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45246
Status
Study Complete
Location
GSK Investigational Site
Teaneck, New Jersey, United States, 07666
Status
Will Be Recruiting
Location
GSK Investigational Site
Los Angeles, California, United States, 90048
Status
Study Complete
Location
GSK Investigational Site
Deerfield Beach, Florida, United States, 33441
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-02-10
Actual study completion date
2009-02-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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