Clinical trial NCT01244230: Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Atopic Dermatitis (AD)
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 Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Atopic Dermatitis
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 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.

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 main itching scores on patient diary
timeFrame: 4 weeks
measure: Changes from baseline in pruritus intensity 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: Hitachinaka-Shi
country: Japan
facility: Investigational Site Number 392012
city: Isumi-Shi
country: Japan
facility: Investigational Site Number 392001
city: Itoshima-Shi
country: Japan
facility: Investigational Site Number 392010
city: Katsushika-Ku
country: Japan
facility: Investigational Site Number 392002
city: Kofu-Shi
country: Japan
facility: Investigational Site Number 392006
city: Komae-Shi
country: Japan
facility: Investigational Site Number 392011
city: Komatsu-Shi
country: Japan
facility: Investigational Site Number 392007
city: Koto-Ku
country: Japan
facility: Investigational Site Number 392003
city: Nagano-Shi
country: Japan
facility: Investigational Site Number 392013
city: Okayama-Shi
country: Japan
facility: Investigational Site Number 392009
city: Osaka-Shi
country: Japan
facility: Investigational Site Number 392008
city: Setagaya-Ku
country: Japan
facility: Investigational Site Number 392004
city: Setagaya-Ku
country: Japan
facility: Investigational Site Number 392005
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: