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

• Status: Completed
• Trial end date: 2011-12-01
• 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 the dose response, safety, and plasma concentrations 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 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