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

Sanofi520 enrolled

Overview

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.

The study duration for each patient is 3 weeks and 3 days: 1. Lead-in period: 1 week 2. Treatment period: 2 weeks 3. Follow-up period: 3 days

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

520

Conditions

Rhinitis Seasonal

Interventions

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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.

Locations (3)

Investigational Site Number 392002

Koganeishi, Japan

Investigational Site Number 392003

Osaka, Japan

Investigational Site Number 392001

Shinjuku-Ku, Japan