Status:
COMPLETED
Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Perennial Allergic Rhinitis (PAR)
Lead Sponsor:
Sanofi
Conditions:
Rhinitis Perennial
Eligibility:
All Genders
6-11 years
Phase:
PHASE2
PHASE3
Brief Summary
Primary Objective: \- To evaluate safety (4 weeks) Secondary Objectives: * To evaluate the long-term safety (12 weeks) * To evaluate the efficacy * To characterize the pharmacokinetic profile
Detailed Description
The study consists of four phases: up to 9-day screening phase, main 4-week treatment phase, up-to 8-week extension phase, and up-to 5-day post-treatment phase.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Aged 6 months through 11 years
- Patients with perennial allergic rhinitis
- Exclusion criteria:
- Neither serum specific IgE antibody or skin reaction is positive for the antigen of perennial allergy.
- Nasal symptom score is 0 for either sneezing or nasal discharge, or sum of these two score is less than 3, or nasal congestion score is 4.
- Patients with vasomotor rhinitis or eosinophilic rhinitis.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01244217
Start Date
October 1 2010
End Date
August 1 2011
Last Update
October 16 2013
Active Locations (15)
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1
Sanofi-Aventis Investigational Site Number 392015
Fukuoka, Japan
2
Sanofi-Aventis Investigational Site Number 392012
Kanazawa, Japan
3
Sanofi-Aventis Investigational Site Number 392001
Kawaguchi-Shi, Japan
4
Sanofi-Aventis Investigational Site Number 392003
Kawasaki-Shi, Japan