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

Last updated: October 12, 2013
Sponsor: Sanofi
Overall Status: Completed

Phase

3

Condition

Allergy

Common Cold

Nasal Obstruction

Treatment

N/A

Clinical Study ID

NCT01306721
EFC11243
U1111-1115-7613
  • Ages > 12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

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

Exclusion

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). Atotal score for nasal symptoms (sneezing, rhinorrhea, and nasal congestion) andeye symptom is less than 6

  • Patients with 2 or more nasal symptoms (sneezing and rhinorrhea) and eye symptomsscore is 4 The above information is not intended to contain all considerations relevant to a patient'spotential participation in a clinical trial.

Study Design

Total Participants: 520
Study Start date:
February 01, 2011
Estimated Completion Date:
April 30, 2011

Study Description

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

Connect with a study center

  • Investigational Site Number 392002

    Koganei-Shi,
    Japan

    Site Not Available

  • Investigational Site Number 392003

    Osaka-Shi,
    Japan

    Site Not Available

  • Investigational Site Number 392001

    Shinjuku-Ku,
    Japan

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.