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

NCT ID: NCT01306721

Last Updated: 2013-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

520 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-04-30

Brief Summary

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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

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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

Conditions

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Rhinitis Seasonal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

fexofenadine HCL (M016455)

Intervention Type DRUG

Pharmaceutical form:tablet Route of administration: oral

pseudoephedrine

Intervention Type DRUG

Pharmaceutical form:tablet

Route of administration: oral

fexofenadine HCL matching placebo

Intervention Type DRUG

Pharmaceutical form:tablet

Route of administration: oral

pseudoephedrine matching placebo

Intervention Type DRUG

Pharmaceutical form:tablet

Route of administration: oral

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)

Group Type EXPERIMENTAL

fexofenadine HCL (M016455)

Intervention Type DRUG

Pharmaceutical form:tablet Route of administration: oral

pseudoephedrine

Intervention Type DRUG

Pharmaceutical form:tablet

Route of administration: oral

fexofenadine HCL matching placebo

Intervention Type DRUG

Pharmaceutical form:tablet

Route of administration: oral

pseudoephedrine matching placebo

Intervention Type DRUG

Pharmaceutical form:tablet

Route of administration: oral

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

Group Type EXPERIMENTAL

fexofenadine HCL (M016455)

Intervention Type DRUG

Pharmaceutical form:tablet Route of administration: oral

pseudoephedrine

Intervention Type DRUG

Pharmaceutical form:tablet

Route of administration: oral

fexofenadine HCL matching placebo

Intervention Type DRUG

Pharmaceutical form:tablet

Route of administration: oral

Interventions

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fexofenadine HCL (M016455)

Pharmaceutical form:tablet Route of administration: oral

Intervention Type DRUG

pseudoephedrine

Pharmaceutical form:tablet

Route of administration: oral

Intervention Type DRUG

fexofenadine HCL matching placebo

Pharmaceutical form:tablet

Route of administration: oral

Intervention Type DRUG

pseudoephedrine matching placebo

Pharmaceutical form:tablet

Route of administration: oral

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Investigational Site Number 392002

Koganeishi, , Japan

Site Status

Investigational Site Number 392003

Osaka, , Japan

Site Status

Investigational Site Number 392001

Shinjuku-Ku, , Japan

Site Status

Countries

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Japan

Other Identifiers

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U1111-1115-7613

Identifier Type: OTHER

Identifier Source: secondary_id

EFC11243

Identifier Type: -

Identifier Source: org_study_id