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
Study complete
Study complete
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:
Enrollment:
508
Primary completion date:
2009-02-10
Observational study model:
Not applicable
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
- Inclusion criteria:
- subject is aged 2 months or older
Inclusion and exclusion criteria
Inclusion 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
Showing 1 - 6 of 53 Results
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
Study complete
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.
Additional information about the trial
Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website