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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01306721
First received: March 1, 2011
Last updated: October 12, 2013
Last verified: October 2013
  Purpose

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.

Condition Intervention Phase
Rhinitis Seasonal
Drug: fexofenadine HCL (M016455)
Drug: pseudoephedrine
Drug: fexofenadine HCL matching placebo
Drug: pseudoephedrine matching placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Nasal findings [ Time Frame: over 2 treatment weeks (from baseline to end of treatment) ] [ Designated as safety issue: No ]
  • Patient's impression [ Time Frame: over 2 treatment weeks (from baseline to end of treatment) ] [ Designated as safety issue: No ]
  • Patient's safety [ Time Frame: over 2 treatment weeks (from baseline to end of treatment) ] [ Designated as safety issue: Yes ]

Enrollment: 520
Study Start Date: February 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: FEX 60 mg

Study medications is administered one hour before or two hours after a meal twice a day.

Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination)

Double-blind treatment period:

1 tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg /pseudoephedrine 60 mg (fixe dose combination)

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

Pharmaceutical form:tablet

Route of administration: oral

Drug: fexofenadine HCL matching placebo

Pharmaceutical form:tablet

Route of administration: oral

Drug: pseudoephedrine matching placebo

Pharmaceutical form:tablet

Route of administration: oral

Experimental: FEX 60 mg/PSE 60 mg

Study medications is administered one hour before or two hours after a meal twice a day.

Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination

Double-blind treatment period:

1 tablet of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination) + 1 placebo tablet of fexofenadine 60 mg / pseudoephedrine 60 mg (fixe dose combination)

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

Pharmaceutical form:tablet

Route of administration: oral

Drug: fexofenadine HCL matching placebo

Pharmaceutical form:tablet

Route of administration: oral

Drug: pseudoephedrine matching placebo

Pharmaceutical form:tablet

Route of administration: oral

Experimental: FEX 60 mg/PSE 120 mg

Study medications is administered one hour before or two hours after a meal twice a day.

Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination)

Double-blind treatment period:

2 tablets of fexofenadine 30 mg/pseudoephedrine 60 mg (fixe dose combination) + 1 placebo tablet of fexofenadine 30 mg

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

Pharmaceutical form:tablet

Route of administration: oral

Drug: fexofenadine HCL matching placebo

Pharmaceutical form:tablet

Route of administration: oral


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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01306721

Locations
Japan
Investigational Site Number 392002
Koganei-Shi, Japan
Investigational Site Number 392003
Osaka-Shi, Japan
Investigational Site Number 392001
Shinjuku-Ku, Japan
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01306721     History of Changes
Other Study ID Numbers: EFC11243, U1111-1115-7613
Study First Received: March 1, 2011
Last Updated: October 12, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Pseudoephedrine
Ephedrine
Fexofenadine
Terfenadine
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Central Nervous System Stimulants
Central Nervous System Agents
Sympathomimetics
Adrenergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on August 26, 2014