Completed
A Randomized, Double Blind, Parallel Group Study for Assessing the Efficacy and Safety of a Twice-daily Fexofenadine HCl 60 mg - Pseudoephedrine HCl 60 mg Combination or Fexofenadine HCl 60 mg - Pseudoephedrine HCl 120 mg Combination Versus Allegra 60 mg in Patients With Seasonal Allergic Rhinitis
Led by Sanofi · Updated on 2013-10-16
520
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Brief Title
Fexofenadine HCL - Pseudoephedrine HCL Combination Versus Allegra in Patients With Seasonal Allergic Rhinitis
Who Can Participate
Eligibility 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.
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