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

Sanofi

Status and phase: Completed; Phase 3; Phase 2

Conditions: Rhinitis Perennial

Treatments: Drug: fexofenadine/Allegra (M016455)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01244217

SFY10717

U1111-1115-3842 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 6 months to 11 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 3 patient groups

Age 6 months - 2 years

Experimental group

Description:

Patients between 6 months and 2 years old

Treatment:

Drug: fexofenadine/Allegra (M016455)

Age 2 - 11 years

Experimental group

Description:

Patients between 2 and 11 years (and under 10.5 kg)

Treatment:

Drug: fexofenadine/Allegra (M016455)

Age 2 - 11 years (and over 10.5 kg)

Experimental group

Description:

Patients between 2 and 11 years (and over 10.5 kg)

Treatment:

Drug: fexofenadine/Allegra (M016455)