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NCT01010971 · ClinicalTrials.gov registry record · Phase 3
Clinical Trial to Assess the Efficacy and Safety of Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol for the Treatment of Seasonal Allergic Rhinitis (SAR) to Mountain Cedar in Subjects 12 Years and Older
A Phase 3 study, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 671
- Enrollment target
NCT01010971: Completed Phase 3 study, sponsored by Sumitomo Pharma America.
NCT01010971 is a Phase 3 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 671 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01010971, a Phase 3 study, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 671 participants
- Enrollment target
Study Summary
This clinical research study will evaluate the safety and effectiveness of two doses of an investigational medication (ciclesonide nasal aerosol) for the treatment of subjects with of seasonal allergic rhinitis (SAR). The study will consist of a Screening Period to confirm study eligibility, followed by a Single-Blind Placebo Run-in period to acclimate subjects to the proper use of the study medication and to assess the subject's severity of SAR symptoms, followed by a 2-week double-blind treatment period to assess the safety and effectiveness of the study medication when given to eligible subjects.
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 two week treatment average - baselin
Interventions
- DRUG Placebo
- DRUG Ciclesonide HFA 160 μg
- DRUG Ciclesonide HFA 80 μg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 671 participants |
| Start Date | 2009-12 |
| Est. Completion | 2010-02 |
| Phase | Phase 3 |
What the finished NCT01010971 record still lists
NCT01010971 is an interventional study that assigns participants to a tested intervention. The registered 671 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 (13% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01010971 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01010971 about?
NCT01010971 is a clinical study titled "Clinical Trial to Assess the Efficacy and Safety of Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol for the Treatment of Seasonal Allergic Rhinitis (SAR) to Mountain Cedar in Subjects 12 Years and Older". This clinical research study will evaluate the safety and effectiveness of two doses of an investigational medication (ciclesonide nasal aerosol) for the treatment of subjects with of seasonal allergic rhinitis (SAR). The study will consist of a Screening Period to confirm study eligibility, followe...
What is the current status of trial NCT01010971?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 671 participants. The study started on 2009-12. Estimated completion is 2010-02.
What interventions are being tested in trial NCT01010971?
The interventions under investigation include: Placebo (DRUG), Ciclesonide HFA 160 μg (DRUG), Ciclesonide HFA 80 μg (DRUG).
Who is sponsoring clinical trial NCT01010971?
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 NCT01010971's enrollment target sits among peer trials
671 544th of 2000 higher than 1,455 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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