Atopic Dermatitis
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 atopic dermatitis
Exclusion criteria
* Main itching scores are 4 or less than 2 on last three consecutive days before registration. * Patients who have itching only on face, head, or diaper area. 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 main itching 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 pruritus intensity 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