Status:
COMPLETED
The Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Perennial Allergic Rhinitis
Eligibility:
All Genders
7-15 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
This is a randomized, double-blind, placebo-controlled, 2-arm parallel-group comparative study to confirm the superiority of TAU-284 over placebo after two weeks of administration of TAU-284 (20 mg/da...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
473 Patients enrolled
Trial Details
Trial ID
NCT01861522
Start Date
April 1 2013
End Date
December 1 2013
Last Update
January 8 2026
Active Locations (2)
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1
Reserch site
Fukuoka, Japan
2
Reserch site
Toyama, Japan