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

Mitsubishi Tanabe Pharma

Status and phase

Completed

Phase 3

Conditions

Perennial Allergic Rhinitis

Treatments

Drug: Bepotastine besilate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01900054

TAU-284-18

Details and patient eligibility

About

The objective of this study is to evaluate the long-term safety and efficacy of TAU-284 (Bepotastine besilate) in pediatric patients with perennial allergic rhinitis for 12 weeks administration.

Full description

This is a multicenter,open-label, single-arm, uncontrolled study to evaluate the safety and efficacy of TAU-284 (20 mg/day) in pediatric patients with perennial allergic rhinitis for 12 weeks administration.

Enrollment

58 patients

Sex

All

Ages

7 to 15 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients aged between 7 and 15 years
Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic criteria
Patients with a mean total score for the three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion] of at least 3 on the basis of symptoms recorded in the nasal allergy diary during the observation period etc.

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 with current or previous history of drug allergy
Patients who concurrently have renal function abnormalities that may cause safety problems etc.