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NCT00570492 · ClinicalTrials.gov registry record · Phase 4
Phase 4 Fluticasone Furoate Nasal Spray (VERAMYST) Long Term Pediatric Growth Study.
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 474
- Enrollment target
NCT00570492: Completed Phase 4 study, sponsored by GlaxoSmithKline.
NCT00570492 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 474 participants, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00570492, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 474 participants
- Enrollment target
Study Summary
The primary objective of this study is to characterize, as accurately as possible, the estimation of the difference in pre-pubescent growth velocities between subjects treated continuously for one year with FFNS 110mcg QD, the highest dose approved for pediatric use in the US, and placebo nasal spray as determined by stadiometry.
Primary Outcome
Height was measured (triplicate measurements) in pre-pubescent pediatric participants via stadiometry at each clinic visit during the entire 76-week study period (16-week Baseline Period, 52-week DB Treatment Period and 8-week Follow-up Period). Growth velocity was calculated by fitting a regression line to all height measurements recorded for the participant during the period and was determined by the slope of the fitted regression line. Change from Baseline was calculated as the value over the
Interventions
- DRUG Placebo nasal spray
- DRUG Fluticasone furoate nasal spray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 474 participants |
| Start Date | 2007-11-26 |
| Est. Completion | 2011-03-17 |
| Phase | Phase 4 |
What the finished NCT00570492 record still lists
NCT00570492 is an interventional study that assigns participants to a tested intervention. The registered 474 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo nasal spray is the first listed.
NCT00570492 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00570492 about?
NCT00570492 is a clinical study titled "Phase 4 Fluticasone Furoate Nasal Spray (VERAMYST) Long Term Pediatric Growth Study.". The primary objective of this study is to characterize, as accurately as possible, the estimation of the difference in pre-pubescent growth velocities between subjects treated continuously for one year with FFNS 110mcg QD, the highest dose approved for pediatric use in the US, and placebo nasal spra...
What is the current status of trial NCT00570492?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 474 participants. The study started on 2007-11-26. Estimated completion is 2011-03-17.
What interventions are being tested in trial NCT00570492?
The interventions under investigation include: Placebo nasal spray (DRUG), Fluticasone furoate nasal spray (DRUG).
Who is sponsoring clinical trial NCT00570492?
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 NCT00570492's enrollment target sits among peer trials
474 182nd of 2000 higher than 1,819 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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