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
Investigational Site Number 392012
Hitachi-Naka, Japan
Investigational Site Number 392001
Isumi, Japan
Investigational Site Number 392010
Itoshima-Shi, Japan
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 main itching scores on patient diary
Time frame: 4 weeks
Changes from baseline in pruritus intensity 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.
Investigational Site Number 392002
Katsushika-ku, Japan
Investigational Site Number 392006
Kofu, Japan
Investigational Site Number 392011
Komae-Shi, Japan
Investigational Site Number 392007
Komatsu-Shi, Japan
Investigational Site Number 392003
Kōtoku, Japan
Investigational Site Number 392013
Nagano, Japan
Investigational Site Number 392009
Okayama, Japan
...and 3 more locations