Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Atopic Dermatitis (AD)

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 Atopic Dermatitis

Conditions
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Atopic Dermatitis

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 atopic dermatitis Exclusion criteria: Main itching scores are 4 or less than 2 on last three consecutive days before registration. Patients who have itching only on face, head, or diaper area. 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 - Type: Experimental | 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 main itching scores on patient diary |  | 4 weeks | 
| Changes from baseline in pruritus intensity scores assessed by investigator or subinvestigator |  | week 2 and 4 | 
| Pharmacokinetic parameters of fexofenadine at steady state; AUC |  | week 4 and 12 |