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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 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 120 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00658918
The ClinicalTrials.gov registry entry for NCT00658918 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00658918 reports 0 study locations.
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.
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