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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 is a Phase 3 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 671 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01010971
The ClinicalTrials.gov registry entry for NCT01010971 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 671 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sumitomo Pharma America, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01010971 reports 0 study locations.
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.
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