Status:
COMPLETED
Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Atopic Dermatitis (AD)
Lead Sponsor:
Sanofi
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
6-11 years
Phase:
PHASE2
PHASE3
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
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01244230
Start Date
November 1 2010
End Date
August 1 2011
Last Update
October 16 2013
Active Locations (13)
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1
Investigational Site Number 392012
Hitachi-Naka, Japan
2
Investigational Site Number 392001
Isumi, Japan
3
Investigational Site Number 392010
Itoshima-Shi, Japan
4
Investigational Site Number 392002
Katsushika-ku, Japan