A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis (Ketotifen Fumarate-controlled, Double-blind, Comparative Study)

Trial Profile

A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis (Ketotifen Fumarate-controlled, Double-blind, Comparative Study)

Completed
Phase of Trial: Phase III

Latest Information Update: 21 Oct 2015

At a glance

  • Drugs Bepotastine (Primary) ; Ketotifen
  • Indications Pruritus
  • Focus Registrational; Therapeutic Use
  • Sponsors Mitsubishi Tanabe Pharma Corporation
  • Most Recent Events

    • 26 May 2015 Mitsubishi Tanabe received approval for bepotastine [Talion and Talion OD tablets] for additional pediatric allergic diseases (for children at least seven years of age) in Japan. This approval was based on efficacy and safety results from trials conducted in pediatric patients in Japan.
    • 13 May 2014 New trial record
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