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NCT01458275 · ClinicalTrials.gov registry record · Phase 3
A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Seasonal Allergic Rhinitis (SAR)
A Phase 3 study of Seasonal Allergic Rhinitis, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 847
- Enrollment target
- 20
- Study locations
NCT01458275: Completed Phase 3 study of Seasonal Allergic Rhinitis, sponsored by Sumitomo Pharma America.
NCT01458275 is a Phase 3 study of Seasonal Allergic Rhinitis that has completed, run by Sumitomo Pharma America. The registered enrollment target is 847 participants, above the 615-participant average among 16 other Seasonal Allergic Rhinitis trials with a reported enrollment target (38% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01458275, a Phase 3 study of Seasonal Allergic Rhinitis, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 847 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a 2-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and premenarchal female subjects 6 to 11 years-old diagnosed with SAR.
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 - baseline. G
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ciclesonide nasal aerosol 37 mcg
- DRUG ciclesonide nasal aerosol 74 mcg
Study Locations (20)
California
- San Jose Multispecialty Medical Group, Inc - Baldwin Park
- WCCT Global, LLC - Costa Mesa
- Premier Health Research Center - Downey
- Allergy, Asthma, Brochitis and Immunology Assoc Medical Group - Fountain Valley
- Pediatric Care Medical Group, Inc. - Huntington Beach
- Pediatric Care Medical Group - Huntington Beach
- Allergy and Asthma Associates of Southern California - Mission Viejo
- CHOC, PSF, AMC, Division of Allergy, Asthma, and Immunology - Orange
- Center for Clinical Trials, LLC - Paramount
- Peninsula Research Associates - Rolling Hills Estates
- Capital Allergy & Respiratory Disease Center - Sacramento
- Allergy Associates Medical Group - San Diego
- Allergy & Asthma Medical Group and Research Center, APC - San Diego
- Bensch Research Associates - Stockton
Colorado
- Asthma & Allergy Associates, PC - Colorado Springs
- Storms Clinical Research Institute - Colorado Springs
- Colorado Allergy and Asthma Centers, PC - Denver
Georgia
- Northeast Georgia Research Center - Gainesville
- DataQuest Medical Research, LLC - Lawerenceville
Arkansas
- Arkansas Pediatric Clinic - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 847 participants |
| Start Date | 2011-11 |
| Est. Completion | 2013-03 |
| Phase | Phase 3 |
What the finished NCT01458275 record still lists
NCT01458275 is an interventional study that assigns participants to a tested intervention. The registered 847 participants enrollment target is mid-sized for trials with a published cap, above the 615-participant average among 16 other Seasonal Allergic Rhinitis trials with a reported enrollment target (38% higher).
The record links to 1 condition, with Seasonal Allergic Rhinitis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01458275 names 20 study sites across 4 states, led by California, Colorado, Georgia.
Frequently Asked Questions
What is clinical trial NCT01458275 about?
NCT01458275 is a clinical study titled "A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Seasonal Allergic Rhinitis (SAR)". This is a 2-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and premenarchal female subjects 6 to 11 years-old diagnosed with SAR.
What is the current status of trial NCT01458275?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 847 participants. The study started on 2011-11. Estimated completion is 2013-03.
What conditions does trial NCT01458275 study?
This clinical trial studies the following conditions: Seasonal Allergic Rhinitis.
What interventions are being tested in trial NCT01458275?
The interventions under investigation include: Placebo (DRUG), Ciclesonide nasal aerosol 37 mcg (DRUG), ciclesonide nasal aerosol 74 mcg (DRUG).
Who is sponsoring clinical trial NCT01458275?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01458275 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Seasonal Allergic Rhinitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01458275's enrollment target sits among peer trials
847 4th of 16 higher than 13 of 16 other Seasonal Allergic Rhinitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Seasonal Allergic Rhinitis 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.
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