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NCT01287364 · ClinicalTrials.gov registry record · Phase 3
Evaluation of a Novel Questionnaire to Assess Patient Satisfaction With and Preference of Intranasal Corticosteroids for the Treatment of Allergic Rhinitis
A Phase 3 study of Perennial Allergic Rhinitis, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 185
- Enrollment target
- 6
- Study locations
NCT01287364: Completed Phase 3 study of Perennial Allergic Rhinitis, sponsored by Sumitomo Pharma America.
NCT01287364 is a Phase 3 study of Perennial Allergic Rhinitis that has completed, run by Sumitomo Pharma America. The registered enrollment target is 185 participants, below the 565-participant average among 4 other Perennial Allergic Rhinitis trials with a reported enrollment target (67% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01287364, a Phase 3 study of Perennial Allergic Rhinitis, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 185 participants
- Enrollment target
- 6
- Study locations
Study Summary
This is an open-label, randomized, multicenter, 2-way crossover study in subjects 12 years or older with perennial allergic rhinitis (PAR) to evaluate the psychometric properties of a novel-patient administered assessment of treatment satisfaction with and preference of an Internasal Corticosteroid (INCS)
Primary Outcome
Reliability for the nine treatment satisfaction subscales was established through internal consistency statistical analyses \[Cronbach's alpha (raw and standardized) coefficients were calculated\]. The correlation coefficients for these analyses ranged from 0.0 to 1.0, with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability.
Conditions Studied
Interventions
- DRUG ciclesonide hydrofluoroalkane (HFA) nasal aerosol
- DRUG mometasone nasal inhalation
Study Locations (6)
California
- Allergy and Asthma Associates of Southern California - Mission Viejo
- Allergy & Asthma Medical Group & Research Center A.P.C. - San Diego
Massachusetts
- Northeast Medical Research Associates, Inc. - North Dartmouth
Minnesota
- Clinical Research Institute - Minneappolis
New Jersey
- Princeton Center for Clinical Research - Skillman
Texas
- Sylvania Research Associates - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 185 participants |
| Start Date | 2011-02 |
| Est. Completion | 2011-04 |
| Phase | Phase 3 |
What the finished NCT01287364 record still lists
NCT01287364 is an interventional study that assigns participants to a tested intervention. The registered 185 participants enrollment target is mid-sized for trials with a published cap, below the 565-participant average among 4 other Perennial Allergic Rhinitis trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Perennial Allergic Rhinitis appearing as the primary indexed condition, and to 2 interventions - of which ciclesonide hydrofluoroalkane (HFA) nasal aerosol is the first listed.
NCT01287364 lists 6 locations in 5 states (California, Massachusetts, Minnesota).
Frequently Asked Questions
What is clinical trial NCT01287364 about?
NCT01287364 is a clinical study titled "Evaluation of a Novel Questionnaire to Assess Patient Satisfaction With and Preference of Intranasal Corticosteroids for the Treatment of Allergic Rhinitis". This is an open-label, randomized, multicenter, 2-way crossover study in subjects 12 years or older with perennial allergic rhinitis (PAR) to evaluate the psychometric properties of a novel-patient administered assessment of treatment satisfaction with and preference of an Internasal Corticosteroid ...
What is the current status of trial NCT01287364?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 185 participants. The study started on 2011-02. Estimated completion is 2011-04.
What conditions does trial NCT01287364 study?
This clinical trial studies the following conditions: Perennial Allergic Rhinitis.
What interventions are being tested in trial NCT01287364?
The interventions under investigation include: ciclesonide hydrofluoroalkane (HFA) nasal aerosol (DRUG), mometasone nasal inhalation (DRUG).
Who is sponsoring clinical trial NCT01287364?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01287364 being conducted?
This trial has 6 study locations across California, Massachusetts, Minnesota, New Jersey, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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