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NCT00684177 · ClinicalTrials.gov registry record · Phase 3
Retapamulin Versus Placebo in Secondarily-Infected Traumatic Lesions (SITL)
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 508
- Enrollment target
NCT00684177: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00684177 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 508 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00684177, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 508 participants
- Enrollment target
Study Summary
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 Outcome
"Clinical Success" at follow-up was defined as "Resolution of clinically meaningful signs and symptoms of infection recorded at baseline including a pus/exudate Skin Infection Rating Scale (SIRS) score of "0". Clinical response at follow-up was classified as "Clinical Failure" for all other cases. The SIRS consists of seven items (pus/exudates, crusting, erythema/inflammation, tissue warmth, tissue edema, itching and pain). Each item has a score ranging from 0 to 6 (0=absent, 6=severe). The SIRS
Interventions
- DRUG Placebo ointment
- DRUG Retapamulin Ointment, 1%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 508 participants |
| Start Date | 2008-05 |
| Est. Completion | 2009-10 |
| Phase | Phase 3 |
What the finished NCT00684177 record still lists
NCT00684177 is an interventional study that assigns participants to a tested intervention. The registered 508 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo ointment is the first listed.
NCT00684177 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00684177 about?
NCT00684177 is a clinical study titled "Retapamulin Versus Placebo in Secondarily-Infected Traumatic Lesions (SITL)". 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 w...
What is the current status of trial NCT00684177?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 508 participants. The study started on 2008-05. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00684177?
The interventions under investigation include: Placebo ointment (DRUG), Retapamulin Ointment, 1% (DRUG).
Who is sponsoring clinical trial NCT00684177?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00684177's enrollment target sits among peer trials
508 737th of 2000 higher than 1,262 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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