Overview

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

Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
0
Participant gender:
All
Summary
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 safety of TAU-284.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mitsubishi Tanabe Pharma Corporation
Treatments:
Bepotastine besilate
Criteria
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 rhinorrhea score and a mean sneezing score of at least 2 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 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 and have a
chance to touch dogs or cats.

- Patients with current or previous history of drug allergy

- Patients who concurrently have renal function abnormalities that may cause safety
problems etc.