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NCT01307319 · ClinicalTrials.gov registry record · Phase 3
Study of an Investigational Nasal Aerosol or Placebo Nasal Aerosol in Children (Ages 6-11) With Seasonal Allergies
A Phase 3 study of Seasonal Allergic Rhinitis and SAR, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 715
- Enrollment target
- 20
- Study locations
NCT01307319 is a Phase 3 study of Seasonal Allergic Rhinitis and SAR that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 715 participants, above the 623-participant average among 16 other Seasonal Allergic Rhinitis trials with a reported enrollment target (15% higher). The trial reports 20 study locations across 8 states.
The verdict
NCT01307319, a Phase 3 study of Seasonal Allergic Rhinitis and SAR, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 715 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the safety and efficacy of an investigational nasal aerosol at two doses compared with placebo nasal aerosol in the treatment of seasonal allergic rhinitis in children (6-11 years of age).
Conditions Studied
Interventions
- DRUG BDP HFA
- DRUG Placebo nasal aerosol
Study Locations (20)
California
- Teva Clinical Study Site - Bell
- Teva Clinical Study Site - Costa Mesa
- Teva Clinical Study Site - Mission Viejo
- Teva Clinical Study Site - Orange
- Teva Clinical Study Site - Paramount
- Teva Clinical Study Site - San Diego
- Teva Clinical Study Site - San Diego
- Teva Clinical Study Site - Stockton
Georgia
- Teva Clinical Study Site - Gainesville
- Teva Clinical Study Site - Lawrenceville
- Teva Clinical Study Site - Savannah
- Teva Clinical Study Site - Stockbridge
Colorado
- Teva Clinical Study Site - Centennial
- Teva Clinical Study Site - Colorado Springs
Minnesota
- Teva Clinical Study Site - Minneapolis
- Teva Clinical Study Site - Plymouth
Alabama
- Teva Clinical Study Site - Oxford
Indiana
- Teva Clinical Study Site - Indianapolis
Maryland
- Teva Clinical Study Site - Bethesda
Missouri
- Teva Clinical Study Site - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 715 participants |
| Start Date | 2011-03 |
| Est. Completion | 2011-08 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01307319
The ClinicalTrials.gov registry entry for NCT01307319 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 715 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 623-participant average among 16 other Seasonal Allergic Rhinitis trials with a reported enrollment target (15% higher). The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 167 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Seasonal Allergic Rhinitis appearing as the primary indexed condition, and to 2 interventions - of which BDP HFA is the first listed.
NCT01307319 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Georgia, Colorado.
Frequently Asked Questions
What is clinical trial NCT01307319 about?
NCT01307319 is a clinical study titled "Study of an Investigational Nasal Aerosol or Placebo Nasal Aerosol in Children (Ages 6-11) With Seasonal Allergies". The purpose of this study is to assess the safety and efficacy of an investigational nasal aerosol at two doses compared with placebo nasal aerosol in the treatment of seasonal allergic rhinitis in children (6-11 years of age).
What is the current status of trial NCT01307319?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 715 participants. The study started on 2011-03. Estimated completion is 2011-08.
What conditions does trial NCT01307319 study?
This clinical trial studies the following conditions: Seasonal Allergic Rhinitis, SAR.
What interventions are being tested in trial NCT01307319?
The interventions under investigation include: BDP HFA (DRUG), Placebo nasal aerosol (DRUG).
Who is sponsoring clinical trial NCT01307319?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01307319 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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