Not Signed In -
Seasonal Affective Disorder |
SAD |
Clinical Trial: A Study to Evaluate a Once-Daily Investigational Nasal Spray in Adults and Adolescents with Seasonal Allergic Rhinitis (SAR)
This study is no longer recruiting patients.
|
Purpose
The primary objective of this study is to compare the efficacy and safety of GW685698X 100 mcg once-daily (QD) aqueous nasal spray with placebo nasal spray in adult and adolescent subjects (12 years of age and older) with seasonal allergic rhinitis (SAR). Subjects will complete diaries twice daily (every 12 hours) reporting on the severity of their SAR symptoms.
| Condition | Intervention | Phase |
|---|---|---|
| Rhinitis, Allergic, Seasonal | Drug: Intranasal GW685698X Aqueous Nasal Spray | Phase III |
MedlinePlus related topics: Allergy
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: 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 100 Mcg for 2 Weeks in Adult and Adolescent Subjects (12 Years of Age and Older) with Seasonal Allergic Rhinitis (SAR)
Further Study Details:
Primary Outcomes: Mean change from baseline (before subject begins active treatment) over the entire treatment period (2 weeks) in daily, reflective total nasal symptom scores
Secondary Outcomes: Mean change from baseline (before subject begins active treatment) over the entire treatment period (2 weeks) in AM, pre-dose, instantaneous total nasal symptom scores; Mean change from baseline over the entire treatment period in daily reflective total ocular symptom scores; Overall evaluation of response to therapy
Expected Total Enrollment: 288
Secondary Outcomes: Mean change from baseline (before subject begins active treatment) over the entire treatment period (2 weeks) in AM, pre-dose, instantaneous total nasal symptom scores; Mean change from baseline over the entire treatment period in daily reflective total ocular symptom scores; Overall evaluation of response to therapy
Expected Total Enrollment: 288
Study start: November 2004
Eligibility
Ages Eligible for Study: 12 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Must be outpatients.
- Diagnosis of SAR.
- Literate in English or native language.
Exclusion Criteria:
- Have a significant concomitant medical condition.
- Use of corticosteroids or other allergy medications during the study.
- Use of tobacco products.
Location Information
Texas
Charles P. Andrews, San Antonio, Texas, 78229, United States
Daniel Freeland, Austin, Texas, 78759, United States
Frank C. Hampel, Jr., New Braunfels, Texas, 78130, United States
Robert L. Jacobs, San Antonio, Texas, 78229, United States
Bruce G. Martin, San Antonio, Texas, 78229, United States
Paul H. Ratner, San Antonio, Texas, 78229, United States
Julius Van Bavel, Austin, Texas, 78731, United States
Study chairs or principal investigators
GSK Clinical Trials, Study Director, GlaxoSmithKline
More Information
Study ID Numbers: FFR30003
Last Updated: July 25, 2005
Record first received: June 23, 2005
ClinicalTrials.gov Identifier: NCT00115622
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-02
Last Updated: July 25, 2005
Record first received: June 23, 2005
ClinicalTrials.gov Identifier: NCT00115622
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-02
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