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NCT00539994 · ClinicalTrials.gov registry record · Phase 2
Retapamulin Ointment in Healthy Adults Nasally Colonized With Staphylococcus Aureus
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
NCT00539994: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT00539994 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 57 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00539994, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
Study Summary
This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and efficacy of Retapamulin ointment, 1% applied twice daily for 3 or 5 days to the anterior nares of healthy adult subjects who are nasally colonized with S. aureus. Approximately 57 healthy subjects who are nasal carriers of S. aureus will be enrolled and stratified in a 2:1 ratio so that at least 38 persistent carriers and 19 intermittent carriers complete the study. Each eligible subject will participate in three screening visits, a treatment period, and two follow-up visits. Each subject's participation in the study will be approximately 6 to 10 weeks from screening to the last follow-up visit. Subjects will participate in up to three screening visits to determine S. aureus culture positivity and colonization status.
Primary Outcome
Area under the plasma concentration curve (AUC) is used to calculate drug clearance and bioavailability using plasma concentration and time curve.
Interventions
- DRUG Placebo
- DRUG Retapamulin
- DRUG retapamulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2007-09 |
| Est. Completion | 2008-01 |
| Phase | Phase 2 |
What the finished NCT00539994 record still lists
NCT00539994 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00539994 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00539994 about?
NCT00539994 is a clinical study titled "Retapamulin Ointment in Healthy Adults Nasally Colonized With Staphylococcus Aureus". This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and efficacy of Retapamulin ointment, 1% applied twice daily for 3 or 5 days to the anterior nares of healthy adult subjects who are nasally colonized with S. aureus. Approximately 57 h...
What is the current status of trial NCT00539994?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2007-09. Estimated completion is 2008-01.
What interventions are being tested in trial NCT00539994?
The interventions under investigation include: Placebo (DRUG), Retapamulin (DRUG), retapamulin (DRUG).
Who is sponsoring clinical trial NCT00539994?
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 NCT00539994's enrollment target sits among peer trials
57 1141st of 2000 higher than 855 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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