Rhinitis Perennial Clinical Trial
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
| Verified date | October 2013 |
| Source | Sanofi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Ministry of Health, Labor and Welfare |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | August 2011 |
| Est. primary completion date | July 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 6 Months to 11 Years |
| Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Japan | Sanofi-Aventis Investigational Site Number 392015 | Fukuoka-Shi | |
| Japan | Sanofi-Aventis Investigational Site Number 392012 | Kanazawa-Shi | |
| Japan | Sanofi-Aventis Investigational Site Number 392001 | Kawaguchi-Shi | |
| Japan | Sanofi-Aventis Investigational Site Number 392003 | Kawasaki-Shi | |
| Japan | Sanofi-Aventis Investigational Site Number 392004 | Kawasaki-Shi | |
| Japan | Sanofi-Aventis Investigational Site Number 392002 | Kita-Ku | |
| Japan | Sanofi-Aventis Investigational Site Number 392011 | Kofu-Shi | |
| Japan | Sanofi-Aventis Investigational Site Number 392014 | Obu-Shi | |
| Japan | Sanofi-Aventis Investigational Site Number 392013 | Seki-Shi | |
| Japan | Sanofi-Aventis Investigational Site Number 392005 | Yokohama-Shi | |
| Japan | Sanofi-Aventis Investigational Site Number 392006 | Yokohama-Shi | |
| Japan | Sanofi-Aventis Investigational Site Number 392007 | Yokohama-Shi | |
| Japan | Sanofi-Aventis Investigational Site Number 392008 | Yokohama-Shi | |
| Japan | Sanofi-Aventis Investigational Site Number 392009 | Yokohama-Shi | |
| Japan | Sanofi-Aventis Investigational Site Number 392010 | Yokohama-Shi |
| Lead Sponsor | Collaborator |
|---|---|
| Sanofi |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of patients with adverse events | 4 weeks | Yes | |
| Primary | The number of clinically significant abnormalities for laboratory findings | 4 weeks | Yes | |
| Secondary | Number of patients with adverse events | 12 weeks | Yes | |
| Secondary | The number of clinically significant abnormalities for laboratory findings | 12 weeks | Yes | |
| Secondary | Changes from baseline in nasal symptom scores on patient diary | 4 weeks | No | |
| Secondary | Changes from baseline in nasal symptom severity scores assessed by investigator or subinvestigator | week 2 and 4 | No | |
| Secondary | Pharmacokinetic parameters of fexofenadine at steady state; AUC | week 4 and 12 | No |