Clinical trial NCT01244217: Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Perennial Allergic Rhinitis (PAR)
Official title: An Open-label, Uncontrolled 4-week Study to Assess the Safety, Efficacy and Pharmacokinetics of Allegra® (Dry Syrup Formulation) 15 mg or 30 mg Twice Daily in Pediatric Patients With Perennial Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Rhinitis Perennial
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-11-19
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: 4 weeks
measure: The number of clinically significant abnormalities for laboratory findings
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of patients with adverse events
timeFrame: 12 weeks
measure: The number of clinically significant abnormalities for laboratory findings
timeFrame: 12 weeks
measure: Changes from baseline in nasal symptom scores on patient diary
timeFrame: 4 weeks
measure: Changes from baseline in nasal symptom severity scores assessed by investigator or subinvestigator
timeFrame: week 2 and 4
measure: Pharmacokinetic parameters of fexofenadine at steady state; AUC
timeFrame: week 4 and 12
Other outcomes:
Locations:
city: Fukuoka-Shi
country: Japan
facility: Sanofi-Aventis Investigational Site Number 392015
city: Kanazawa-Shi
country: Japan
facility: Sanofi-Aventis Investigational Site Number 392012
city: Kawaguchi-Shi
country: Japan
facility: Sanofi-Aventis Investigational Site Number 392001
city: Kawasaki-Shi
country: Japan
facility: Sanofi-Aventis Investigational Site Number 392003
city: Kawasaki-Shi
country: Japan
facility: Sanofi-Aventis Investigational Site Number 392004
city: Kita-Ku
country: Japan
facility: Sanofi-Aventis Investigational Site Number 392002
city: Kofu-Shi
country: Japan
facility: Sanofi-Aventis Investigational Site Number 392011
city: Obu-Shi
country: Japan
facility: Sanofi-Aventis Investigational Site Number 392014
city: Seki-Shi
country: Japan
facility: Sanofi-Aventis Investigational Site Number 392013
city: Yokohama-Shi
country: Japan
facility: Sanofi-Aventis Investigational Site Number 392005
city: Yokohama-Shi
country: Japan
facility: Sanofi-Aventis Investigational Site Number 392006
city: Yokohama-Shi
country: Japan
facility: Sanofi-Aventis Investigational Site Number 392007
city: Yokohama-Shi
country: Japan
facility: Sanofi-Aventis Investigational Site Number 392008
city: Yokohama-Shi
country: Japan
facility: Sanofi-Aventis Investigational Site Number 392009
city: Yokohama-Shi
country: Japan
facility: Sanofi-Aventis Investigational Site Number 392010
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: