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NCT01033825 · ClinicalTrials.gov registry record · Phase 3
Study of the Effects of Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol on Hypothalamic-Pituitary-Adrenal (HPA) Axis
A Phase 3 study, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 310
- Enrollment target
NCT01033825: Completed Phase 3 study, sponsored by Sumitomo Pharma America.
NCT01033825 is a Phase 3 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 310 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01033825, a Phase 3 study, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 310 participants
- Enrollment target
Study Summary
To demonstrate the effects of ciclesonide applied as a nasal aerosol and ciclesonide aqueous (AQ) nasal spray on hypothalamic-pituitary-adrenal axis.
Primary Outcome
AUC(0-24h) will be computed using the linear trapezoidal rule based on the actual time of serum cortisol drawing. AUC(0-24) is then approximated by the sum of the areas of trapezoids. The trapezoid for each time interval is based on the actual times of non-missing cortisol values, and is defined by the actual time interval as the base, the line connecting the two cortisol values, and the two vertical sides at the two time points. Raw data is presented for baseline values (i.e. mean/SD), while in
Interventions
- DRUG Ciclesonide HFA Nasal Aerosol 320 mcg
- DRUG Ciclesonide HFA Nasal Aerosol 160 mcg
- DRUG HFA Nasal Aerosol placebo
- DRUG Ciclesonide Aqueous Nasal Spray 200 mcg
- DRUG AQ Nasal Spray Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 310 participants |
| Start Date | 2010-01 |
| Est. Completion | 2010-05 |
| Phase | Phase 3 |
What the finished NCT01033825 record still lists
NCT01033825 is an interventional study that assigns participants to a tested intervention. The registered 310 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 (60% lower).
The record links to 0 conditions, and to 5 interventions - of which Ciclesonide HFA Nasal Aerosol 320 mcg is the first listed.
NCT01033825 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01033825 about?
NCT01033825 is a clinical study titled "Study of the Effects of Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol on Hypothalamic-Pituitary-Adrenal (HPA) Axis". To demonstrate the effects of ciclesonide applied as a nasal aerosol and ciclesonide aqueous (AQ) nasal spray on hypothalamic-pituitary-adrenal axis.
What is the current status of trial NCT01033825?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 310 participants. The study started on 2010-01. Estimated completion is 2010-05.
What interventions are being tested in trial NCT01033825?
The interventions under investigation include: Ciclesonide HFA Nasal Aerosol 320 mcg (DRUG), Ciclesonide HFA Nasal Aerosol 160 mcg (DRUG), HFA Nasal Aerosol placebo (DRUG), Ciclesonide Aqueous Nasal Spray 200 mcg (DRUG), AQ Nasal Spray Placebo (DRUG).
Who is sponsoring clinical trial NCT01033825?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01033825's enrollment target sits among peer trials
310 1107th of 2000 higher than 892 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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