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.