NCT00987233

A Study Comparing the Bioequivalence of Triamcinolone Acetonide Aqueous Nasal Spray (Apotex, Inc.) to That of Nasacort® AQ Nasal Spray (Sanofi-Aventis Pharmaceutical Products, Inc.) In the Treatment of Seasonal Allergic Rhinitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: Apotex Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A randomized, double-blind, placebo-controlled parallel-group study, comparing the bioequivalence of triamcinolone acetonide aqueous nasal spray (Apotex, Inc.) to that of Nasacort® AQ nasal spray (Sanofi-Aventis Pharmaceutical Products, Inc.) in the treatment of seasonal allergic rhinitis.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	triamcinolone acetonide aqueous nasal spray (Apotex Inc.)	It is to be self-administered; the dosing regimen will be 2 sprays (actuations) into each nostril, once daily. This is the dosing regimen during placebo lead-in and randomized treatment phases. Each actuation of active treatment is equivalent to 55 ug of triamcinolone acetonide, for a total daily dose of 220ug triamcinolone acetonide per day.
DRUG	triamcinolone acetonide aqueous nasal spray (Nasacort® AQ)	It is to be self-administered; the dosing regimen will be 2 sprays (actuations) into each nostril, once daily. This is the dosing regimen during placebo lead-in and randomized treatment phases. Each actuation of active treatment is equivalent to 55 ug of triamcinolone acetonide, for a total daily dose of 220ug triamcinolone acetonide per day.
DRUG	Placebo	It is to be self-administered; the dosing regimen will be 2 sprays (actuations) into each nostril, once daily. This is the dosing regimen during placebo lead-in and randomized treatment phases. Each actuation of active treatment is equivalent to 55 ug of triamcinolone acetonide, for a total daily dose of 220ug triamcinolone acetonide per day.

Timeline

• First posted: 2009-09-30
• Last updated: 2009-09-30

Locations

1 site across 1 country: United States