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

Primary Purpose

Rhinitis Seasonal

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

fexofenadine HCL (M016455)

pseudoephedrine

fexofenadine HCL matching placebo

pseudoephedrine matching placebo

About this trial

This is an interventional treatment trial for Rhinitis Seasonal

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Investigational Site Number 392002
Investigational Site Number 392003
Investigational Site Number 392001

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

FEX 60 mg

FEX 60 mg/PSE 60 mg

FEX 60 mg/PSE 120 mg

Arm Description

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)

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)

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01306721

First Posted

March 1, 2011

Last Updated

October 12, 2013

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01306721

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rhinitis Seasonal

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

520 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FEX 60 mg

Arm Type

Active Comparator

Arm Description

Arm Title

FEX 60 mg/PSE 60 mg

Arm Type

Experimental

Arm Description

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)

Arm Title

FEX 60 mg/PSE 120 mg

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

fexofenadine HCL (M016455)

Intervention Description

Pharmaceutical form:tablet Route of administration: oral

Intervention Type

Drug

Intervention Name(s)

pseudoephedrine

Intervention Description

Pharmaceutical form:tablet Route of administration: oral

Intervention Type

Drug

Intervention Name(s)

fexofenadine HCL matching placebo

Intervention Description

Pharmaceutical form:tablet Route of administration: oral

Intervention Type

Drug

Intervention Name(s)

pseudoephedrine matching placebo

Intervention Description

Pharmaceutical form:tablet Route of administration: oral

Primary Outcome Measure Information:

Title

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

Time Frame