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

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Ephedrine; Fexofenadine; Pseudoephedrine; Terfenadine

Criteria

Inclusion criteria:

• Patients with seasonal allergic rhinitis (SAR): Patients with a history of SAR symptoms during the season when cedar pollen levels are increased for at least 2-years

Exclusion criteria:

• At the start of the placebo lead-in period:

• Patients who are negative for IgE Antibody test

• Expected nasal congestion score is less than 2

• The last 3 days of the lead-in period:

• Nasal congestion scores are 2 or more and not all 4

• Patients with all nasal symptoms (sneezing, rhinorrhea, and nasal congestion). A total score for nasal symptoms (sneezing, rhinorrhea, and nasal congestion) and eye symptom is less than 6

• Patients with 2 or more nasal symptoms (sneezing and rhinorrhea) and eye symptoms score is 4

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.