Single Dose Crossover Study of Patient Preference for Unscented Nasonex® Nasal Spray Versus Scented Flonase® Nasal Spray (Study P04207)(COMPLETED)
This study has been completed.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00817050
First received: January 5, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
| Tracking Information | |
|---|---|
| First Received Date ICMJE | January 5, 2009 |
| Last Updated Date | January 5, 2009 |
| Start Date ICMJE | December 2004 |
| Primary Completion Date | January 2005 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Overall product preference based on subjects' answer to the question "which product do you prefer overall" [ Time Frame: On the study day, after dose of each product ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | No Changes Posted |
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Single Dose Crossover Study of Patient Preference for Unscented Nasonex® Nasal Spray Versus Scented Flonase® Nasal Spray (Study P04207)(COMPLETED) |
| Official Title ICMJE | A Preference Evaluation of Nasonex® Nasal Spray (Unscented) vs. Flonase® Nasal Spray (Scented) in Subjects With Symptomatic Allergic Rhinitis (AR) - Single-Dose Cross-Over |
| Brief Summary | This was a one-day single dose trial conducted to compare patient's preference for Nasonex® (mometasone) versus Flonase® nasal spray. Each patient was randomized to take one dose (2 sprays in each nostril) of Nasonex or Flonase. Thirty minutes later, each patient was to take one dose of the opposite medication. Questionnaires were given to each patient after each drug dose to evaluate patient product preference. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Interventional |
| Study Phase | Phase 4 |
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Condition ICMJE | Allergic Rhinitis |
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 100 |
| Completion Date | January 2005 |
| Primary Completion Date | January 2005 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 18 Years to 65 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Not Provided |
| Administrative Information | |
| NCT Number ICMJE | NCT00817050 |
| Other Study ID Numbers ICMJE | P04207 |
| Has Data Monitoring Committee | No |
| Responsible Party | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| Study Sponsor ICMJE | Schering-Plough |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Schering-Plough |
| Verification Date | January 2009 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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