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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
fexofenadine/Allegra (M016455)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

6 Months - 11 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 392012
  • Investigational Site Number 392001
  • Investigational Site Number 392010
  • Investigational Site Number 392002
  • Investigational Site Number 392006
  • Investigational Site Number 392011
  • Investigational Site Number 392007
  • Investigational Site Number 392003
  • Investigational Site Number 392013
  • Investigational Site Number 392009
  • Investigational Site Number 392008
  • Investigational Site Number 392004
  • Investigational Site Number 392005

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Age 6 months - 2 years

Age 2 - 11 years

Age 2 - 11 years (and over 10.5 kg)

Arm Description

Patients between 6 months and 2 years old - Type: Experimental

Patients between 2 and 11 years (and under 10.5 kg)

Patients between 2 and 11 years (and over 10.5 kg)

Outcomes

Primary Outcome Measures

Number of patients with adverse events
The number of clinically significant abnormalities for laboratory findings

Secondary Outcome Measures

Number of patients with adverse events
The number of clinically significant abnormalities for laboratory findings
Changes from baseline in main itching scores on patient diary
Changes from baseline in pruritus intensity scores assessed by investigator or subinvestigator
Pharmacokinetic parameters of fexofenadine at steady state; AUC

Full Information

First Posted
November 15, 2010
Last Updated
October 12, 2013
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01244230
Brief Title
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

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Age 6 months - 2 years
Arm Type
Experimental
Arm Description
Patients between 6 months and 2 years old - Type: Experimental
Arm Title
Age 2 - 11 years
Arm Type
Experimental
Arm Description
Patients between 2 and 11 years (and under 10.5 kg)
Arm Title
Age 2 - 11 years (and over 10.5 kg)
Arm Type
Experimental
Arm Description
Patients between 2 and 11 years (and over 10.5 kg)
Intervention Type
Drug
Intervention Name(s)
fexofenadine/Allegra (M016455)
Intervention Description
Pharmaceutical form:dry syrup formulation to be suspended in water Route of administration: oral
Primary Outcome Measure Information:
Title
Number of patients with adverse events
Time Frame
4 weeks
Title
The number of clinically significant abnormalities for laboratory findings
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Number of patients with adverse events
Time Frame
12 weeks
Title
The number of clinically significant abnormalities for laboratory findings
Time Frame
12 weeks
Title
Changes from baseline in main itching scores on patient diary
Time Frame
4 weeks
Title
Changes from baseline in pruritus intensity scores assessed by investigator or subinvestigator
Time Frame
week 2 and 4
Title
Pharmacokinetic parameters of fexofenadine at steady state; AUC
Time Frame
week 4 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 392012
City
Hitachinaka-Shi
Country
Japan
Facility Name
Investigational Site Number 392001
City
Isumi-Shi
Country
Japan
Facility Name
Investigational Site Number 392010
City
Itoshima-Shi
Country
Japan
Facility Name
Investigational Site Number 392002
City
Katsushika-Ku
Country
Japan
Facility Name
Investigational Site Number 392006
City
Kofu-Shi
Country
Japan
Facility Name
Investigational Site Number 392011
City
Komae-Shi
Country
Japan
Facility Name
Investigational Site Number 392007
City
Komatsu-Shi
Country
Japan
Facility Name
Investigational Site Number 392003
City
Koto-Ku
Country
Japan
Facility Name
Investigational Site Number 392013
City
Nagano-Shi
Country
Japan
Facility Name
Investigational Site Number 392009
City
Okayama-Shi
Country
Japan
Facility Name
Investigational Site Number 392008
City
Osaka-Shi
Country
Japan
Facility Name
Investigational Site Number 392004
City
Setagaya-Ku
Country
Japan
Facility Name
Investigational Site Number 392005
City
Setagaya-Ku
Country
Japan

12. IPD Sharing Statement

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

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