Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115089
Status:
COMPLETED
Last Update Posted:
2005-11-11
First Post:
2005-06-20
Brief Title:
7 Day Study of Mast Cell Inhibitor R926112 in Patients With Symptomatic Seasonal Allergic Rhinitis
Sponsor:
Rigel Pharmaceuticals
Organization:
Rigel Pharmaceuticals
Study Overview
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 Rhinitis
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
Seven hundred fifty patients with histories of seasonal allergies will be screened in late summer and early fall at 25 sites across the US 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None