clinical trial · NCT01840605
A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis
DermatitisAtopicBepotastine besilateketotifen fumarate
brief summary
The objective of this study is to verify the non-inferiority of TAU-284 to ketotifen fumarate dry syrup in the change in the severity of pruritus after the treatment period.
started
Mar 1, 2013
primary completion
Nov 1, 2013
completion
Nov 1, 2013
last updated
Jan 8, 2026
detailed description
This is a randomized, double-blind, parallel-group comparative study to demonstrate the noninferiority of TAU-284 to ketotifen fumarate in pediatric patients with atopic dermatitis, as assessed by the primary endpoint of the change from baseline in pruritus score after 2-week treatment with TAU-284 (20 mg/day) or ketotifen fumarate dry syrup (2 g/day); and to investigate the safety, and plasma concentrations of TAU-284.
official title
A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis (Ketotifen Fumarate-controlled, Double-blind, Comparative Study)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol