A Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis

Tanabe Pharma Corporation

Status and phase

Completed

Phase 3

Conditions

Perennial Allergic Rhinitis

Treatments

Drug: Placebo

Drug: TAU-284

Study type

Interventional

Funder types

Industry

Identifiers

NCT01425632

TAU-284-17

Details and patient eligibility

About

The objectives of this study are: to confirm the superiority of TAU-284 over placebo after two weeks of administration to pediatric patients with perennial allergic rhinitis, and to investigate the dose response, safety, and plasma concentrations of TAU-284.

Full description

This is a randomized, double-blind, placebo-controlled, 3-arm parallel-group comparative study to confirm the superiority of TAU-284 over placebo after two weeks of administration of TAU-284 (10 mg/day or 20 mg/day) or placebo to pediatric patients with perennial allergic rhinitis, with "the change from baseline in total nasal symptom score (total score for the three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion])" as the primary endpoint; and to investigate the dose response, safety, and plasma concentrations of TAU-284.

Enrollment

490 patients

Sex

All

Ages

7 to 15 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients aged between 7 and 15 years
Patients with a weight of at least 20 kg
Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic criteria
Patients with a mean rhinorrhea score of at least 2 and a mean total score for the three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion] of at least 4 on the basis of symptoms recorded in the nasal allergy diary during the observation period

Exclusion criteria

Patients with vasomotor rhinitis or eosinophilic rhinitis
Patients who have concurrent nasal disease that may affect the efficacy of TAU-284
Patients with a history of any of the nasal surgical procedures
Patients who have a positive result for pollen antigens which are dispersed during the study period
Patients who have a positive result for dog dander or cat dander antigen
Patients with current or previous history of drug allergy
Patients who concurrently have renal function abnormalities that may cause safety problems