Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Perennial Allergic Rhinitis (PAR)

Study Overview
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Brief Summary
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Primary Objective: - To evaluate safety (4 weeks) Secondary Objectives: To evaluate the long-term safety (12 weeks) To evaluate the efficacy To characterize the pharmacokinetic profile

Detailed Description
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The study consists of four phases: up to 9-day screening phase, main 4-week treatment phase, up-to 8-week extension phase, and up-to 5-day post-treatment phase.

Official Title
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An Open-label, Uncontrolled 4-week Study to Assess the Safety, Efficacy and Pharmacokinetics of Allegra® (Dry Syrup Formulation) 15 mg or 30 mg Twice Daily in Pediatric Patients With Perennial Allergic Rhinitis

Conditions
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Rhinitis Perennial

Intervention / Treatment
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* Drug: fexofenadine/Allegra (M016455)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Aged 6 months through 11 years Patients with perennial allergic rhinitis Exclusion criteria: Neither serum specific IgE antibody or skin reaction is positive for the antigen of perennial allergy. Nasal symptom score is 0 for either sneezing or nasal discharge, or sum of these two score is less than 3, or nasal congestion score is 4. Patients with vasomotor rhinitis or eosinophilic rhinitis. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Age 6 months - 2 years<br>Patients between 6 months and 2 years old | Drug: fexofenadine/Allegra (M016455)<br>* Pharmaceutical form:dry syrup formulation to be suspended in water Route of administration: oral<br>|
| Experimental: Age 2 - 11 years<br>Patients between 2 and 11 years (and under 10.5 kg) | Drug: fexofenadine/Allegra (M016455)<br>* Pharmaceutical form:dry syrup formulation to be suspended in water Route of administration: oral<br>|
| Experimental: Age 2 - 11 years (and over 10.5 kg)<br>Patients between 2 and 11 years (and over 10.5 kg) | Drug: fexofenadine/Allegra (M016455)<br>* Pharmaceutical form:dry syrup formulation to be suspended in water Route of administration: oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events |  | 4 weeks | 
| The number of clinically significant abnormalities for laboratory findings |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events |  | 12 weeks | 
| The number of clinically significant abnormalities for laboratory findings |  | 12 weeks | 
| Changes from baseline in nasal symptom scores on patient diary |  | 4 weeks | 
| Changes from baseline in nasal symptom severity scores assessed by investigator or subinvestigator |  | week 2 and 4 | 
| Pharmacokinetic parameters of fexofenadine at steady state; AUC |  | week 4 and 12 |