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NCT01378429 · ClinicalTrials.gov registry record · Phase 3
Safety Study of the Potential Inhibitory Effects of Ciclesonide Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal Axis in Subjects 6-11 Years With Perennial Allergic Rhinitis
A Phase 3 study, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 89
- Enrollment target
NCT01378429: Completed Phase 3 study, sponsored by Sumitomo Pharma America.
NCT01378429 is a Phase 3 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 89 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01378429, a Phase 3 study, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 89 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, safety study of the effects of ciclesonide nasal aerosol (74 mcg) on the HPA axis when administered once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR.
Primary Outcome
Area under the concentration-time curve from time 0 to 24 hours \[AUC(0-24h)\]. Timepoints at which data were collected: 0, 2, 4, 8, 12, 16, and 24 at week 0 and 6.
Interventions
- DRUG Placebo
- DRUG ciclesonide nasal aerosol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2011-07 |
| Est. Completion | 2011-11 |
| Phase | Phase 3 |
What the finished NCT01378429 record still lists
NCT01378429 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01378429 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01378429 about?
NCT01378429 is a clinical study titled "Safety Study of the Potential Inhibitory Effects of Ciclesonide Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal Axis in Subjects 6-11 Years With Perennial Allergic Rhinitis". This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, safety study of the effects of ciclesonide nasal aerosol (74 mcg) on the HPA axis when administered once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR.
What is the current status of trial NCT01378429?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 89 participants. The study started on 2011-07. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01378429?
The interventions under investigation include: Placebo (DRUG), ciclesonide nasal aerosol (DRUG).
Who is sponsoring clinical trial NCT01378429?
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 NCT01378429's enrollment target sits among peer trials
89 1738th of 2000 higher than 262 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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