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
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Pharmaceutical form:dry syrup formulation to be suspended in water Route of administration: oral
Sanofi-Aventis Investigational Site Number 392015
Fukuoka, Japan
Sanofi-Aventis Investigational Site Number 392012
Kanazawa, Japan
Sanofi-Aventis Investigational Site Number 392001
Number of patients with adverse events
Time frame: 4 weeks
The number of clinically significant abnormalities for laboratory findings
Time frame: 4 weeks
Number of patients with adverse events
Time frame: 12 weeks
The number of clinically significant abnormalities for laboratory findings
Time frame: 12 weeks
Changes from baseline in nasal symptom scores on patient diary
Time frame: 4 weeks
Changes from baseline in nasal symptom severity scores assessed by investigator or subinvestigator
Time frame: week 2 and 4
Pharmacokinetic parameters of fexofenadine at steady state; AUC
Time frame: week 4 and 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Kawaguchi-Shi, Japan
Sanofi-Aventis Investigational Site Number 392003
Kawasaki-Shi, Japan
Sanofi-Aventis Investigational Site Number 392004
Kawasaki-Shi, Japan
Sanofi-Aventis Investigational Site Number 392002
Kita-ku, Japan
Sanofi-Aventis Investigational Site Number 392011
Kofu, Japan
Sanofi-Aventis Investigational Site Number 392014
Obu-Shi, Japan
Sanofi-Aventis Investigational Site Number 392013
Seki-Shi, Japan
Sanofi-Aventis Investigational Site Number 392005
Yokohama, Japan
...and 5 more locations