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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014