NCT01244230

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

October 16, 2013

Status Verified

October 1, 2013

Enrollment Period

8 months

First QC Date

November 15, 2010

Last Update Submit

October 12, 2013

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

  • Number of patients with adverse events

    4 weeks

  • The number of clinically significant abnormalities for laboratory findings

    4 weeks

Secondary Outcomes (5)

  • Number of patients with adverse events

    12 weeks

  • The number of clinically significant abnormalities for laboratory findings

    12 weeks

  • 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

  • Pharmacokinetic parameters of fexofenadine at steady state; AUC

    week 4 and 12

Study Arms (3)

Age 6 months - 2 years

EXPERIMENTAL

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

Drug: fexofenadine/Allegra (M016455)

Age 2 - 11 years

EXPERIMENTAL

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

Drug: fexofenadine/Allegra (M016455)

Age 2 - 11 years (and over 10.5 kg)

EXPERIMENTAL

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

Drug: fexofenadine/Allegra (M016455)

Interventions

fexofenadine/Allegra (M016455)DRUG

Pharmaceutical form:dry syrup formulation to be suspended in water Route of administration: oral

Age 2 - 11 yearsAge 2 - 11 years (and over 10.5 kg)Age 6 months - 2 years

Eligibility Criteria

Age6 Months - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Aged 6 months through 11 years
  • Patients with atopic dermatitis

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Investigational Site Number 392012

Hitachi-Naka, Japan

Location

Investigational Site Number 392001

Isumi, Japan

Location

Investigational Site Number 392010

Itoshima-Shi, Japan

Location

Investigational Site Number 392002

Katsushika-ku, Japan

Location

Investigational Site Number 392006

Kofu, Japan

Location

Investigational Site Number 392011

Komae-Shi, Japan

Location

Investigational Site Number 392007

Komatsu-Shi, Japan

Location

Investigational Site Number 392003

Kōtoku, Japan

Location

Investigational Site Number 392013

Nagano, Japan

Location

Investigational Site Number 392009

Okayama, Japan

Location

Investigational Site Number 392008

Osaka, Japan

Location

Investigational Site Number 392004

Setagaya-Ku, Japan

Location

Investigational Site Number 392005

Setagaya-Ku, Japan

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

fexofenadine

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2010

First Posted

November 19, 2010

Study Start

November 1, 2010

Primary Completion

July 1, 2011

Study Completion

August 1, 2011

Last Updated

October 16, 2013

Record last verified: 2013-10

Locations

JP(13)