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OpenTrials
Completed

NCT Number: NCT01244230

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

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

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

6 month–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Investigational Site Number 392012, Hitachi-Naka, Japan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fexofenadine/Allegra (M016455)

Drug

Pharmaceutical form:dry syrup formulation to be suspended in water

Route of administration: oral

Primary outcomes

  1. Number of patients with adverse events

    Time frame: 4 weeks

  2. The number of clinically significant abnormalities for laboratory findings

    Time frame: 4 weeks

Secondary outcomes

  1. Number of patients with adverse events

    Time frame: 12 weeks

  2. The number of clinically significant abnormalities for laboratory findings

    Time frame: 12 weeks

  3. Changes from baseline in main itching scores on patient diary

    Time frame: 4 weeks

  4. Changes from baseline in pruritus intensity scores assessed by investigator or subinvestigator

    Time frame: week 2 and 4

  5. Pharmacokinetic parameters of fexofenadine at steady state; AUC

    Time frame: week 4 and 12

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 19, 2010
Registry last updated
Oct 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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