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NCT00658918 · ClinicalTrials.gov registry record · Phase 3
To Assess the Safety of Ciclesonide, Applied as a Nasal Spray at Three Dose Levels, in the Treatment of Perennial Allergic Rhinitis in Pediatrics (BY9010/M1-405)
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 120
- Enrollment target
NCT00658918: Completed Phase 3 study, sponsored by AstraZeneca.
NCT00658918 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 120 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00658918, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 120 participants
- Enrollment target
Study Summary
The primary objective of this study is to demonstrate the safety of three dose levels of ciclesonide administered as an intranasal spray for six weeks, 200µg, 100µg or 25µg, once daily, in pediatric patients (ages 2-5 years) with PAR. The secondary objective is to measure serum concentrations of ciclesonide and its active metabolite under steady state conditions at three time points corresponding to the presumed peak and trough exposure after six weeks of administration. In addition, reflective (24-hour) total nasal symptom score (TNSS) over the six weeks of treatment at various timepoints and a physician assessment of nasal symptoms at endpoint were summarized.
Interventions
- DRUG Placebo
- DRUG Ciclesonide nasal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2004-09 |
| Est. Completion | 2005-11 |
| Phase | Phase 3 |
What the finished NCT00658918 record still lists
NCT00658918 is an interventional study that assigns participants to a tested intervention. The registered 120 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 (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00658918 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00658918 about?
NCT00658918 is a clinical study titled "To Assess the Safety of Ciclesonide, Applied as a Nasal Spray at Three Dose Levels, in the Treatment of Perennial Allergic Rhinitis in Pediatrics (BY9010/M1-405)". The primary objective of this study is to demonstrate the safety of three dose levels of ciclesonide administered as an intranasal spray for six weeks, 200µg, 100µg or 25µg, once daily, in pediatric patients (ages 2-5 years) with PAR. The secondary objective is to measure serum concentrations of cic...
What is the current status of trial NCT00658918?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2004-09. Estimated completion is 2005-11.
What interventions are being tested in trial NCT00658918?
The interventions under investigation include: Placebo (DRUG), Ciclesonide nasal (DRUG).
Who is sponsoring clinical trial NCT00658918?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00658918's enrollment target sits among peer trials
120 1619th of 2000 higher than 361 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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