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NCT01654536 · ClinicalTrials.gov registry record · Phase 4
A 6 Month Safety Study Of Ciclesonide Nasal Aerosol (Zetonna®) And Ciclesonide Nasal Spray (Omnaris®) In Subjects 12 Years And Older With Perennial Allergic Rhinitis (PAR)
A Phase 4 study of Perennial Allergic Rhinitis, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 4
- Development phase
- 737
- Enrollment target
- 20
- Study locations
NCT01654536: Completed Phase 4 study of Perennial Allergic Rhinitis, sponsored by Sumitomo Pharma America.
NCT01654536 is a Phase 4 study of Perennial Allergic Rhinitis that has completed, run by Sumitomo Pharma America. The registered enrollment target is 737 participants, above the 427-participant average among 4 other Perennial Allergic Rhinitis trials with a reported enrollment target (73% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01654536, a Phase 4 study of Perennial Allergic Rhinitis, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 737 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a 6 month, multicenter, randomized, open label, parallel group, study to evaluate the nasal safety of ciclesonide nasal aerosol and ciclesonide aqueous nasal spray administered once daily to male and female subjects 12 years and older diagnosed with PAR.
Conditions Studied
Interventions
- DRUG ciclesonide nasal aerosol
- DRUG ciclesonide nasal spray
Study Locations (20)
California
- Allergy & Asthma Associates of Southern California - Mission Viejo
- CHOC PSF AMC - Division of Allergy, Asthma and Immunology - Orange
- Allergy Associates Medical Group Inc. - San Diego
- Bensch Research Associates - Stockton
New Jersey
- Ocean Allergy & Respiratory Research Center - Brick
- Atlantic Research Center, LLC - Ocean City
- Princeton Center for Clinical Research - Skillman
Georgia
- DataQuest Medical Research LLC - Lawerenceville
- Asthma & Allergy Consultants, PC - Lilburn
Massachusetts
- Medical Education and Research Management Services of New England - Gardner
- Northeast Medical Research Associates, Inc. - North Dartmouth
North Carolina
- Allergy and Asthma Center of NC, PA - High Point
- North Carolina Clinical Research - Raleigh
Colorado
- Storms Clinical Research Institute - Colorado Springs
Maryland
- Gordon D Raphael, MD - Bethesda
Michigan
- Respiratory Medicine Research Institute of Michigan, PLC - Ypsilanti
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 737 participants |
| Start Date | 2012-09 |
| Est. Completion | 2013-07 |
| Phase | Phase 4 |
What the finished NCT01654536 record still lists
NCT01654536 is an interventional study that assigns participants to a tested intervention. The registered 737 participants enrollment target is mid-sized for trials with a published cap, above the 427-participant average among 4 other Perennial Allergic Rhinitis trials with a reported enrollment target (73% higher).
The record links to 1 condition, with Perennial Allergic Rhinitis appearing as the primary indexed condition, and to 2 interventions - of which ciclesonide nasal aerosol is the first listed.
NCT01654536 names 20 study sites across 12 states, led by California, New Jersey, Georgia.
Frequently Asked Questions
What is clinical trial NCT01654536 about?
NCT01654536 is a clinical study titled "A 6 Month Safety Study Of Ciclesonide Nasal Aerosol (Zetonna®) And Ciclesonide Nasal Spray (Omnaris®) In Subjects 12 Years And Older With Perennial Allergic Rhinitis (PAR)". This is a 6 month, multicenter, randomized, open label, parallel group, study to evaluate the nasal safety of ciclesonide nasal aerosol and ciclesonide aqueous nasal spray administered once daily to male and female subjects 12 years and older diagnosed with PAR.
What is the current status of trial NCT01654536?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 737 participants. The study started on 2012-09. Estimated completion is 2013-07.
What conditions does trial NCT01654536 study?
This clinical trial studies the following conditions: Perennial Allergic Rhinitis.
What interventions are being tested in trial NCT01654536?
The interventions under investigation include: ciclesonide nasal aerosol (DRUG), ciclesonide nasal spray (DRUG).
Who is sponsoring clinical trial NCT01654536?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01654536 being conducted?
This trial has 20 study locations across California, Colorado, Georgia, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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