Status:
COMPLETED
A 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 the do...
Detailed Description
This is a randomized, double-blind, placebo-controlled, 3-arm parallel-group comparative study to confirm the superiority of TAU-284 over placebo after two weeks of administration of TAU-284 (10 mg/da...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
490 Patients enrolled
Trial Details
Trial ID
NCT01425632
Start Date
August 1 2011
End Date
December 1 2011
Last Update
January 7 2026
Active Locations (5)
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1
Reserch site
Chūbu, Japan
2
Reserch site
Hokuriku, Japan
3
Reserch site
Kanto, Japan
4
Reserch site
Kinki, Japan