Protocol Summary for 113407
| Protocol Id: | 113407 |
| Secondary Ids: |
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| Title: | Drug Use Investigation for ALLERMIST |
| Phase: | phase 4 |
| Acronym: | |
| FDA Regulated Intervention?: | No |
| Section 801 Clinical Trial?: | |
| Delayed Posting: | |
| IND/IDE Protocol?: | no |
| Study Type: | Observational |
| Oversight Authority: |
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| Collaborators: |
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| Brief Summary: | To investigate possible problems or questions in safety and efficacy of ALLERMIST Nasal Spray in Japanese subjects with allergic rhinitis under the practical use conditions |
| Detailed Description: | |
| Record Verification Date: | June 2011 |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | December 2009 |
| Study Completion Date: | May 2011 |
| Study Completion Date Type: | Actual |
| Primary Completion Date: | September 2010 |
| Primary Completion Date Type: | Actual |
| Study Design: | Other |
| Time Perspective: | Other |
| Biospecimen Retention: | None retained |
| Biospecimen Description: | |
| Primary Outcomes: |
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| Conditions: |
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| Keywords: |
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| Study Population: | Subjects who have allergic rhinitis for which the indication of ALLERMIST has been approved and who are using ALLERMIST for the first time. |
| Sampling Method: | Non probability |
| Eligibility Criteria: | 
Click to view inclusion/exclusion criteria
Inclusion Criteria: |
| Gender: | Both |
| Minimum Age: | |
| Maximum Age: | |
| Enrollment: | 2000 |
| Enrollment Type: | Actual |
| Healthy Volunteers?: | none |
| Central Contact: | Call Center |
| Central Contact Phone: | 877-379-3718 |
| Central Contact Email: | GSKClinicalSupportHD@gsk.com |
| Backup Central Contact: | |
| Backup Central Contact Phone: | |
| Backup Central Contact Email: | |
| Overall Study Official: | GSK Clinical Trials |
| Overall Study Official Affiliation: | GlaxoSmithKline |
| Overall Study Official Role: | Study Director |
| Responsible Party Name/Official Title: | Cheri Hudson; Clinical Disclosure Advisor |
| Responsible Party Organization: | GSK Clinical Disclosure |
| Location and Contact Information: | No locations currently recruiting for this study. |