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Completed

NCT Number: NCT01306721

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

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.

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Key information

Conditions

Rhinitis Seasonal

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site Number 392002, Koganeishi, Japan

Loading trial locations.

About this study

The study duration for each patient is 3 weeks and 3 days:

  • Lead-in period: 1 week
  • Treatment period: 2 weeks
  • Follow-up period: 3 days

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fexofenadine HCL (M016455)

Drug

Pharmaceutical form:tablet Route of administration: oral

pseudoephedrine

Drug

Pharmaceutical form:tablet

Route of administration: oral

fexofenadine HCL matching placebo

Drug

Pharmaceutical form:tablet

Route of administration: oral

pseudoephedrine matching placebo

Drug

Pharmaceutical form:tablet

Route of administration: oral

Primary outcomes

  1. Changes in the nasal congestion score based on the patient's symptom diary

    Time frame: over 2 treatment weeks (from baseline to end of treatment)

Secondary outcomes

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

    Time frame: over 2 treatment weeks (from baseline to end of treatment)

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

    Time frame: over 2 treatment weeks (from baseline to end of treatment)

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

    Time frame: over 2 treatment weeks (from baseline to end of treatment)

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

    Time frame: over 2 treatment weeks (from baseline to end of treatment)

  5. Nasal findings

    Time frame: over 2 treatment weeks (from baseline to end of treatment)

  6. Patient's impression

    Time frame: over 2 treatment weeks (from baseline to end of treatment)

  7. Patient's safety

    Time frame: over 2 treatment weeks (from baseline to end of treatment)

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 2, 2011
Registry last updated
Oct 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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