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NCT00659841 · ClinicalTrials.gov registry record · Phase 3
To Assess the Safety and Efficacy of Ciclesonide, Applied as a Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (BY9010/M1-401)
A Phase 3 study of Hay Fever and Rhinitis, Allergic, Seasonal, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 302
- Enrollment target
- 6
- Study locations
NCT00659841: Completed Phase 3 study of Hay Fever and Rhinitis, Allergic, Seasonal, sponsored by AstraZeneca.
NCT00659841 is a Phase 3 study of Hay Fever and Rhinitis, Allergic, Seasonal that has completed, run by AstraZeneca. The registered enrollment target is 302 participants, below the 388-participant average among 3 other Hay Fever trials with a reported enrollment target (22% lower). The trial reports 6 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00659841, a Phase 3 study of Hay Fever and Rhinitis, Allergic, Seasonal, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 302 participants
- Enrollment target
- 6
- Study locations
Study Summary
The primary objective of this study is to demonstrate the efficacy of ciclesonide applied as a nasal spray once daily in patients with SAR. The secondary objectives are to evaluate Quality-of-Life and safety.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ciclesonide
Study Locations (6)
Texas
- Altana/Nycomed - Austin
- Altana/Nycomed - Austin
- Altana/Nycomed - Kerrville
- Altana/Nycomed - New Braunfels
- Altana/Nycomed - San Antonio
- Altana/Nycomed - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 302 participants |
| Start Date | 2003-12 |
| Est. Completion | 2005-02 |
| Phase | Phase 3 |
What the finished NCT00659841 record still lists
NCT00659841 is an interventional study that assigns participants to a tested intervention. The registered 302 participants enrollment target is mid-sized for trials with a published cap, below the 388-participant average among 3 other Hay Fever trials with a reported enrollment target (22% lower).
The record links to 2 conditions, with Hay Fever appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00659841 lists 6 locations in 1 state (Texas).
Frequently Asked Questions
What is clinical trial NCT00659841 about?
NCT00659841 is a clinical study titled "To Assess the Safety and Efficacy of Ciclesonide, Applied as a Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (BY9010/M1-401)". The primary objective of this study is to demonstrate the efficacy of ciclesonide applied as a nasal spray once daily in patients with SAR. The secondary objectives are to evaluate Quality-of-Life and safety.
What is the current status of trial NCT00659841?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 302 participants. The study started on 2003-12. Estimated completion is 2005-02.
What conditions does trial NCT00659841 study?
This clinical trial studies the following conditions: Hay Fever, Rhinitis, Allergic, Seasonal.
What interventions are being tested in trial NCT00659841?
The interventions under investigation include: Placebo (DRUG), Ciclesonide (DRUG).
Who is sponsoring clinical trial NCT00659841?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00659841 being conducted?
This trial has 6 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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