Rhinitis Perennial
Conditions
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.
Interventions
Pharmaceutical form:dry syrup formulation to be suspended in water Route of administration: oral
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 11 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with adverse events | 4 weeks |
| The number of clinically significant abnormalities for laboratory findings | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in nasal symptom scores on patient diary | 4 weeks |
| Number of patients with adverse events | 12 weeks |
| Pharmacokinetic parameters of fexofenadine at steady state; AUC | week 4 and 12 |
| Changes from baseline in nasal symptom severity scores assessed by investigator or subinvestigator | week 2 and 4 |
| The number of clinically significant abnormalities for laboratory findings | 12 weeks |
Countries
Japan
Outcome results
None listed