NCT00637611

Single-Center, Double-Blind, Randomized , Parallel Study Comparing Onset of Action, Efficacy & Safety of a Single-Dose of Fexofenadine HCl 180 mg vs Montelukast Na 10 mg & Placebo in Treating Seasonal Allergic Rhinitis Subjects in an Allergen Exposure Unit

Single-Center, Double-Blind, Randomized , Parallel Study Comparing Onset of Action, Efficacy & Safety of a Single-Dose of Fexofenadine HCl 180 mg vs Montelukast Na 10 mg & Placebo in Treating Seasonal Allergic Rhinitis Subjects in an Allergen Exposure Unit (Study I)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,010 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to determine the efficacy and onsets of action of single-dose fexofenadine hydrochloride 180 mg and montelukast sodium 10 mg relative to placebo. Secondary objectives are to compare the safety and efficacy of fexofenadine hydrochloride 180 mg, montelukast sodium 10 mg, and placebo

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Fexofenadine HCl

Timeline

• Start date: 2003-02-01
• Completion: 2003-04-01
• First posted: 2008-03-18
• Last updated: 2011-01-12

Locations

1 site across 1 country: United States