Status:
COMPLETED
A Long-Term 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 objective of this study is to evaluate the long-term safety and efficacy of TAU-284 (Bepotastine besilate) in pediatric patients with perennial allergic rhinitis for 12 weeks administration.
Detailed Description
This is a multicenter,open-label, single-arm, uncontrolled study to evaluate the safety and efficacy of TAU-284 (20 mg/day) in pediatric patients with perennial allergic rhinitis for 12 weeks administ...
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 total score for the three major nasal symptoms \[sneezing, rhinorrhea, and nasal congestion\] of at least 3 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 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 :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT01900054
Start Date
June 1 2013
End Date
November 1 2013
Last Update
January 7 2026
Active Locations (1)
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1
Reserch site
Kanagawa, Japan