Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01458275
The ClinicalTrials.gov registry entry for NCT01458275 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 847 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 615-participant average among 16 other Seasonal Allergic Rhinitis trials with a reported enrollment target (38% higher). The listed sponsor is Sumitomo Pharma America, which has 168 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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.
-
Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR)
COMPLETED · Phase 3
-
Safety and Efficacy of Ciclesonide in Pediatric Patients (6 to 11 Years of Age) With Seasonal Allergic Rhinitis (BY9010/M1-417)
COMPLETED · Phase 3
-
A Study Evaluating the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
COMPLETED · Phase 3
-
Study of an Investigational Nasal Aerosol or Placebo Nasal Aerosol in Children (Ages 6-11) With Seasonal Allergies
COMPLETED · Phase 3
-
Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients
COMPLETED · Phase 3
-
Dose Selection Study of Efficacy and Safety of Different Doses of Grass MATA MPL and Grass MATA Using mEECs™
COMPLETED · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.