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NCT01401465 · ClinicalTrials.gov registry record · Phase 3
Study To Evaluate Patient Preference, Satisfaction And Efficacy Of a Nasal Aerosol Versus an Aqueous Nasal Spray
A Phase 3 study, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 327
- Enrollment target
NCT01401465: Completed Phase 3 study, sponsored by Sumitomo Pharma America.
NCT01401465 is a Phase 3 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 327 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01401465, a Phase 3 study, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 327 participants
- Enrollment target
Study Summary
This is a randomized, multicenter, 2-way crossover study in subjects 12 years or older with perennial allergic rhinitis (PAR) to evaluate patient preference, satisfaction and efficacy of ciclesonide nasal aerosol versus mometasone aqueous nasal spray. A novel patient-administered assessment, developed and validated to measure patient satisfaction with and preference of intranasal corticosteroids (INCS) for the treatment of allergic rhinitis (AR), is utilized in this study.
Primary Outcome
For the 17 individual items, patients were forced to choose their preference between ciclesonide and mometasone (item choices: 1 = prefer ciclesonide; 0 = prefer mometasone). The items for the Total Preference Score assessed 16 treatment attributes and one overall treatment preference: Ease of use, Convenience, Flexibility in daily activities, Taste, Use in public, Smell, Less "run out" of nose, Longer relief, Less "run down" of throat, Symptom relief, If both were the same price, Better appeara
Interventions
- DRUG ciclesonide
- DRUG mometasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 327 participants |
| Start Date | 2011-07 |
| Est. Completion | 2011-11 |
| Phase | Phase 3 |
What the finished NCT01401465 record still lists
NCT01401465 is an interventional study that assigns participants to a tested intervention. The registered 327 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 2 interventions - of which ciclesonide is the first listed.
NCT01401465 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01401465 about?
NCT01401465 is a clinical study titled "Study To Evaluate Patient Preference, Satisfaction And Efficacy Of a Nasal Aerosol Versus an Aqueous Nasal Spray". This is a randomized, multicenter, 2-way crossover study in subjects 12 years or older with perennial allergic rhinitis (PAR) to evaluate patient preference, satisfaction and efficacy of ciclesonide nasal aerosol versus mometasone aqueous nasal spray. A novel patient-administered assessment, develop...
What is the current status of trial NCT01401465?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 327 participants. The study started on 2011-07. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01401465?
The interventions under investigation include: ciclesonide (DRUG), mometasone (DRUG).
Who is sponsoring clinical trial NCT01401465?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01401465's enrollment target sits among peer trials
327 1075th of 2000 higher than 926 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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