NIPH Clinical Trials Search

Phase II/III clinical trial of TO-206 - Evaluation of efficacy and safety in patients with Japanese cedar pollinosis -

Basic Information

Recruitment status	completed
Health condition(s) or Problem(s) studied	Japanese cedar pollinosis
Date of first enrollment	03/07/2014
Target sample size	920
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : TO-206 INN of investigational material : - Therapeutic category code : 449 Other antiallergic agents Dosage and Administration for Investigational material : One tablet of TO-206 tablet, administered once daily, shall be placed under the tongue and left there for at least 1 minute before being swallowed. Subjects should not gargle, eat, or drink for 5 minutes post-dose. control material(s) Generic name etc : Placebo INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : -

Outcome(s)

Primary Outcome	efficacy Total nasal symptom medication score (TNSMS) during symptom peak period of the first season (2015)
Secondary Outcome	efficacy Total nasal ocular symptom medication score (TNOSMS) during symptom peak period of the first season (2015) safety Adverse Events (AEs) and Adverse Drug Reactions (ADRs)

Key inclusion & exclusion criteria

Age minimum	>= 5age old
Age maximum	<= 64age old
Gender	Both
Include criteria	1)Patients with specific IgE against cedar pollen : class 3 or more. 2)Patients who have a clinical history of cedar pollinosis in 2013 and 2014 cedar pollen seasons.
Exclude criteria	1)Patients with perennial allergic rhinitis, medication-derived rhinitis, vasomotor rhinitis or non-allergic rhinitis during therapy. 2)Patients who have developed asthmatic attack within 5 years before the pre-treatment observation visit. 3)Patients who have received specific immunotherapy for cedar pollinosis in history.