Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Atopic Dermatitis (AD)

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

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

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: fexofenadine/Allegra (M016455)

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Japan
  • Hitachinaka-Shi, Japan
    • Investigational Site Number 392012
  • Isumi-Shi, Japan
    • Investigational Site Number 392001
  • Itoshima-Shi, Japan
    • Investigational Site Number 392010
  • Katsushika-Ku, Japan
    • Investigational Site Number 392002
  • Kofu-Shi, Japan
    • Investigational Site Number 392006
  • Komae-Shi, Japan
    • Investigational Site Number 392011
  • Komatsu-Shi, Japan
    • Investigational Site Number 392007
  • Koto-Ku, Japan
    • Investigational Site Number 392003
  • Nagano-Shi, Japan
    • Investigational Site Number 392013
  • Okayama-Shi, Japan
    • Investigational Site Number 392009
  • Osaka-Shi, Japan
    • Investigational Site Number 392008
  • Setagaya-Ku, Japan
    • Investigational Site Number 392004
  • Setagaya-Ku, Japan
    • Investigational Site Number 392005

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 months to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Age 2 - 11 years; Patients between 2 and 11 years (and under 10.5 kg)	Drug: fexofenadine/Allegra (M016455); Pharmaceutical form:dry syrup formulation to be suspended in water Route of administration: oral
Experimental: Age 2 - 11 years (and over 10.5 kg); Patients between 2 and 11 years (and over 10.5 kg)	Drug: fexofenadine/Allegra (M016455); Pharmaceutical form:dry syrup formulation to be suspended in water Route of administration: oral
Experimental: Age 6 months - 2 years; Patients between 6 months and 2 years old - Type: Experimental	Drug: fexofenadine/Allegra (M016455); Pharmaceutical form:dry syrup formulation to be suspended in water Route of administration: oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with adverse events	4 weeks
The number of clinically significant abnormalities for laboratory findings	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients with adverse events	12 weeks
The number of clinically significant abnormalities for laboratory findings	12 weeks
Pharmacokinetic parameters of fexofenadine at steady state; AUC	week 4 and 12
Changes from baseline in main itching scores on patient diary	4 weeks
Changes from baseline in pruritus intensity scores assessed by investigator or subinvestigator	week 2 and 4

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: November 15, 2010
• First Submitted That Met QC Criteria: November 17, 2010
• First Posted (Estimate): November 19, 2010

Study Record Updates

• Last Update Posted (Estimate): October 16, 2013
• Last Update Submitted That Met QC Criteria: October 12, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Fexofenadine
• Other Study ID Numbers: SFY10718; U1111-1115-4048 (Other Identifier: UTN)