NCT00783146

Efficacy and Safety of Desloratadine vs. Fexofenadine 180 mg. vs. Placebo for Treating Seasonal Allergic Rhinitis (SAR) (Study P04054)

A Placebo Controlled Study of the Efficacy and Safety of Desloratadine vs. Fexofenadine 180 mg. in the Treatment of Subjects With Symptomatic Seasonal Allergic Rhinitis (SAR)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 728 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This was a randomized, double-blind, parallel-group, multicenter study that used both an active control (fexofenadine) and a placebo control to evaluate desloratadine 5 mg once daily during a 15-day treatment period. The active treatments and placebo were allocated in a 2:2:1 ratio.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	desloratadine	desloratadine, 5 mg oral tablets, once daily for 15 days
DRUG	fexofenadine	fexofenadine, 180 mg tablets, once daily for 15 days; for purposes of blinding, fexofenadine tablets were over encapsulated
DRUG	placebo	placebo, once daily for 15 days

Timeline

• Start date: 2004-08-01
• Primary completion: 2004-10-01
• Completion: 2004-10-01
• First posted: 2008-10-31
• Last updated: 2024-08-15