Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Atopic Dermatitis (AD)
- Conditions
- Atopic Dermatitis
- Interventions
- Drug: fexofenadine/Allegra (M016455)
- Registration Number
- NCT01244230
- Lead Sponsor
- Sanofi
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Age 6 months - 2 years fexofenadine/Allegra (M016455) Patients between 6 months and 2 years old - Type: Experimental Age 2 - 11 years fexofenadine/Allegra (M016455) Patients between 2 and 11 years (and under 10.5 kg) Age 2 - 11 years (and over 10.5 kg) fexofenadine/Allegra (M016455) Patients between 2 and 11 years (and over 10.5 kg)
- Primary Outcome Measures
Name Time Method The number of clinically significant abnormalities for laboratory findings 4 weeks Number of patients with adverse events 4 weeks
- Secondary Outcome Measures
Name Time Method 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 Number of patients with adverse events 12 weeks The number of clinically significant abnormalities for laboratory findings 12 weeks Pharmacokinetic parameters of fexofenadine at steady state; AUC week 4 and 12
Trial Locations
- Locations (13)
Investigational Site Number 392008
🇯🇵Osaka-Shi, Japan
Investigational Site Number 392005
🇯🇵Setagaya-Ku, Japan
Investigational Site Number 392004
🇯🇵Setagaya-Ku, Japan
Investigational Site Number 392010
🇯🇵Itoshima-Shi, Japan
Investigational Site Number 392006
🇯🇵Kofu-Shi, Japan
Investigational Site Number 392007
🇯🇵Komatsu-Shi, Japan
Investigational Site Number 392013
🇯🇵Nagano-Shi, Japan
Investigational Site Number 392001
🇯🇵Isumi-Shi, Japan
Investigational Site Number 392003
🇯🇵Koto-Ku, Japan
Investigational Site Number 392009
🇯🇵Okayama-Shi, Japan
Investigational Site Number 392012
🇯🇵Hitachinaka-Shi, Japan
Investigational Site Number 392002
🇯🇵Katsushika-Ku, Japan
Investigational Site Number 392011
🇯🇵Komae-Shi, Japan