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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00197262 |
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Date of registration:
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15/09/2005 |
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Primary sponsor: |
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Public title:
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Once-Daily Investigational Nasal Spray In Adults And Adolescents With Seasonal Allergic Rhinitis (SAR)
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Scientific title:
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 2 Weeks in Adult and Adolescent Subjects (12 Years of Age and Older) With Seasonal Allergic Rhinitis (SAR) |
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Date of first enrolment:
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August 2005 |
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Target sample size:
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288 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00197262 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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GSK Clinical Trial, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Must be outpatients.
- Diagnosis of SAR.
- Literate in English or native language.
Exclusion criteria:
- Have a significant concomitant medical condition.
- Use corticosteroids or other allergy medications during the study.
- Use tobacco products.
Age minimum:
12 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Rhinitis
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Intervention(s)
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Drug: GW685698X Aqueous Nasal Spray
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Primary Outcome(s)
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Mean change from baseline over the entire treatment period in daily, reflective total nasal symptom scores.
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Secondary Outcome(s)
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1) Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous total nasal symptom scores. 2) Mean change from baseline in daily reflective total ocular symptom scores. 3) overall evaluation of response to therapy.
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Secondary ID(s)
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FFR104861
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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