Clinical Trial: 7 Day Study of Mast Cell Inhibitor, R926112, in Patients With Symptomatic Seasonal Allergic Rhinitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase II Multi-Center, Randomized, Double-Blind, Active and Placebo-Controlled 7 Day Study of Mast Cell Inhibitor, R926112, in Patients With Symptomatic Seasonal Allergic Rhini
Brief Summary: This is a study of the effectiveness and safety of a new nasal spray for the relief of the symptoms of seasonal allergies. The agents being compared are: R926112 (a novel anti-allergy medicine), Beconase (beclomethasone dipropionate, an established FDA approved steroid treatment), and an inactive placebo. The study hypothesis is that R926112 will be superior to placebo at the end of a week of testing and evaluation. The study does not have the power to determine how R926112 compares to Beconase.
Detailed Summary: Seven hundred fifty patients with histories of seasonal allergies will be screened in late summer and early fall at 25 sites across the U.S. Approximately 375 patients, based on severity of symptoms will be randomized among the treatments (150 to R926112, 150 to placebo, 75 to Beconase). During, and for about 2-3 weeks prior to the study, patients will have to abstain from other anti-allergy medications. Patients will fill out diary cards two times per day to record their symptoms. The entire study should take between 2-4 weeks.
Sponsor: Rigel Pharmaceuticals
Current Primary Outcome: Change in total nasal symptom score from baseline over time
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in individual symptoms
- Global therapeutic response
- Quality of life score
Original Secondary Outcome: Same as current
Information By: Rigel Pharmaceuticals
Dates:
Date Received: June 20, 2005
Date Started: July 2005
Date Completion: September 2005
Last Updated: November 9, 2005
Last Verified: November 2005
