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

Rhinitis Seasonal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306721
• Other study ID #: EFC11243
• Secondary ID: U1111-1115-7613
• Status: Completed
• Phase: Phase 3
• First received: March 1, 2011
• Last updated: October 12, 2013
• Start date: February 2011
• Est. completion date: April 2011

Study information

• Verified date: October 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 520
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis Seasonal
• Rhinitis, Allergic, Seasonal

Intervention

Drug:
• fexofenadine HCL (M016455)
Pharmaceutical form:tablet Route of administration: oral
• pseudoephedrine
Pharmaceutical form:tablet Route of administration: oral
• fexofenadine HCL matching placebo
Pharmaceutical form:tablet Route of administration: oral
• pseudoephedrine matching placebo
Pharmaceutical form:tablet Route of administration: oral

Locations

Country	Name	City	State
Japan	Investigational Site Number 392002	Koganei-Shi
Japan	Investigational Site Number 392003	Osaka-Shi
Japan	Investigational Site Number 392001	Shinjuku-Ku

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the nasal congestion score based on the patient's symptom diary		over 2 treatment weeks (from baseline to end of treatment)	No
Secondary	Changes in the total score of 4 symptoms, each nasal symptom (sneezing, rhinorrhea, and nasal congestion) and eye symptom		over 2 treatment weeks (from baseline to end of treatment)	No
Secondary	Changes in total score of 4 symptoms on a daily, day-time, and night-time bases		over 2 treatment weeks (from baseline to end of treatment)	No
Secondary	Changes in each symptom (sneezing, rhinorrhea, nasal congestion, and eye symptoms) score and the daily activity impairment score		over 2 treatment weeks (from baseline to end of treatment)	No
Secondary	Changes in each symptom score and the daily activity impairment score on a daily, day-time and night-time basis		over 2 treatment weeks (from baseline to end of treatment)	No
Secondary	Nasal findings		over 2 treatment weeks (from baseline to end of treatment)	No
Secondary	Patient's impression		over 2 treatment weeks (from baseline to end of treatment)	No
Secondary	Patient's safety		over 2 treatment weeks (from baseline to end of treatment)	Yes