Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Perennial Allergic Rhinitis (PAR)

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Fexofenadine

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.