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NCT01451541 · ClinicalTrials.gov registry record · Phase 3
A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Perennial Allergic Rhinitis (PAR).
A Phase 3 study, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 848
- Enrollment target
NCT01451541: Completed Phase 3 study, sponsored by Sumitomo Pharma America.
NCT01451541 is a Phase 3 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 848 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01451541, a Phase 3 study, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 848 participants
- Enrollment target
Study Summary
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR.
Primary Outcome
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Gr
Interventions
- DRUG Placebo
- DRUG Ciclesonide nasal aerosol 37 mcg
- DRUG ciclesonide nasal aerosol 74 mcg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 848 participants |
| Start Date | 2011-10 |
| Est. Completion | 2012-12 |
| Phase | Phase 3 |
What the finished NCT01451541 record still lists
NCT01451541 is an interventional study that assigns participants to a tested intervention. The registered 848 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01451541 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01451541 about?
NCT01451541 is a clinical study titled "A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Perennial Allergic Rhinitis (PAR).". This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of ciclesonide nasal aerosol 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 NCT01451541?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 848 participants. The study started on 2011-10. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01451541?
The interventions under investigation include: Placebo (DRUG), Ciclesonide nasal aerosol 37 mcg (DRUG), ciclesonide nasal aerosol 74 mcg (DRUG).
Who is sponsoring clinical trial NCT01451541?
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 NCT01451541's enrollment target sits among peer trials
848 389th of 2000 higher than 1,611 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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