CompletedPhase 3

Study in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis (SAR)

United States340 participantsStarted 2009-12-31

Plain-language summary

The purpose of the study is to assess the efficacy and safety of an investigational nasal aerosol compared with placebo nasal aerosol in the treatment of seasonal allergic rhinitis.

Who can participate

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Informed Consent * Male or female subjects 12 years of age or older * Documented history of season allergic rhinitis to mountain cedar pollen * General good health * Other criteria apply Exclusion Criteria: * History of physical findings of nasal pathology (within 60 days prior to screening visit) * Participation in any investigational drug study 30 days preceding screening visit * History of respiratory infection/disorder with 14 days preceding screening visit * Use of any prohibited concomitant medications * Other criteria apply

What they're measuring

Change From Baseline in Average Subject-Reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period

Timeframe: Baseline (Days -3 to 0), and Days 1-15

Trial details

NCT IDNCT01024608

SponsorTeva Branded Pharmaceutical Products R&D, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-02-28

Results submitted2012-04-23

View on ClinicalTrials.gov More Seasonal Allergic Rhinitis trials