drugset / Trial / NCT01306721

Fexofenadine HCL - Pseudoephedrine HCL Combination Versus Allegra in Patients With Seasonal Allergic Rhinitis

NCT01306721

Phase 3 Completed 520 enrolled Sanofi
RandomizedParallel-groupDouble-blindTreatment

Summary

Primary Objective: \- To evaluate the efficacy on the nasal congestion of a twice-daily fexofenadine HCl 60 mg - pseudoephedrine HCl 60 mg combination (FEX60/PSE60) and fexofenadine HCl 60 mg - pseudoephedrine HCl 120 mg combination (FEX60/PSE120) versus fexofenadine HCl 60 mg (FEX60) in patients with seasonal allergic rhinitis (SAR). Secondary Objectives: * To evaluate the efficacy of a twice-daily FEX60/PSE60 and FEX60/PSE120 versus FEX60 on nasal symptoms (sneezing, rhinorrhea, and nasal congestion), eye symptom, and daily activity impairment. * To assess the safety of a twice-daily FEX60/PSE60 and FEX60/PSE120 versus FEX60.

Timeline

Start
2011-02
Primary completion
2011-04
Completion
2011-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Fexofenadine Unknown 60 mg Oral
Subject Pseudoephedrine Small molecule 60 mg Oral
Subject Pseudoephedrine Small molecule 120 mg Oral