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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rhinitis Seasonal

Intervention: fexofenadine HCL (M016455) (Drug); pseudoephedrine (Drug); fexofenadine HCL matching placebo (Drug); pseudoephedrine matching placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Clinical Sciences & Operations, Study Director, Affiliation: Sanofi

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.

Clinical Details

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 AllegraŽ 60 mg in Patients With Seasonal Allergic Rhinitis

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

Primary outcome: Changes in the nasal congestion score based on the patient's symptom diary

Secondary outcome:

Changes in the total score of 4 symptoms, each nasal symptom (sneezing, rhinorrhea, and nasal congestion) and eye symptom

Changes in total score of 4 symptoms on a daily, day-time, and night-time bases

Changes in each symptom (sneezing, rhinorrhea, nasal congestion, and eye symptoms) score and the daily activity impairment score

Changes in each symptom score and the daily activity impairment score on a daily, day-time and night-time basis

Nasal findings

Patient's impression

Patient's safety

Detailed 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

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Investigational Site Number 392002, Koganei-Shi, Japan

Investigational Site Number 392003, Osaka-Shi, Japan

Investigational Site Number 392001, Shinjuku-Ku, Japan

Additional Information

Starting date: February 2011
Last updated: October 12, 2013

Page last updated: August 23, 2015

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