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

NCT01244230 Phase 2/Phase 3 COMPLETED

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

Details

Lead sponsor	Sanofi
Phase	Phase 2/Phase 3
Status	COMPLETED
Enrolment	100
Start date	2010-11
Completion	2011-08

Conditions

• Atopic Dermatitis

Interventions

• fexofenadine/Allegra (M016455)

Primary outcomes

• Number of patients with adverse events — 4 weeks
• The number of clinically significant abnormalities for laboratory findings — 4 weeks

Countries

Japan