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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01244230
First received: November 15, 2010
Last updated: October 12, 2013
Last verified: October 2013
  Purpose

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

Condition Intervention Phase
Atopic Dermatitis
Drug: fexofenadine/Allegra (M016455)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of patients with adverse events [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • The number of clinically significant abnormalities for laboratory findings [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of patients with adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • The number of clinically significant abnormalities for laboratory findings [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Changes from baseline in main itching scores on patient diary [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in pruritus intensity scores assessed by investigator or subinvestigator [ Time Frame: week 2 and 4 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters of fexofenadine at steady state; AUC [ Time Frame: week 4 and 12 ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: November 2010
Study Completion Date: August 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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


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

Ages Eligible for Study:   6 Months to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244230

Locations
Japan
Investigational Site Number 392012
Hitachinaka-Shi, Japan
Investigational Site Number 392001
Isumi-Shi, Japan
Investigational Site Number 392010
Itoshima-Shi, Japan
Investigational Site Number 392002
Katsushika-Ku, Japan
Investigational Site Number 392006
Kofu-Shi, Japan
Investigational Site Number 392011
Komae-Shi, Japan
Investigational Site Number 392007
Komatsu-Shi, Japan
Investigational Site Number 392003
Koto-Ku, Japan
Investigational Site Number 392013
Nagano-Shi, Japan
Investigational Site Number 392009
Okayama-Shi, Japan
Investigational Site Number 392008
Osaka-Shi, Japan
Investigational Site Number 392004
Setagaya-Ku, Japan
Investigational Site Number 392005
Setagaya-Ku, Japan
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01244230     History of Changes
Other Study ID Numbers: SFY10718, U1111-1115-4048
Study First Received: November 15, 2010
Last Updated: October 12, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fexofenadine
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014