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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 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 57 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00539994
The ClinicalTrials.gov registry entry for NCT00539994 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00539994 reports 0 study locations.
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.
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