Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01244230
Recruitment Status : Completed
First Posted : November 19, 2010
Last Update Posted : October 16, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE November 15, 2010
First Posted Date  ICMJE November 19, 2010
Last Update Posted Date October 16, 2013
Study Start Date  ICMJE November 2010
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2010)
  • Number of patients with adverse events [ Time Frame: 4 weeks ]
  • The number of clinically significant abnormalities for laboratory findings [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2010)
  • Number of patients with adverse events [ Time Frame: 12 weeks ]
  • The number of clinically significant abnormalities for laboratory findings [ Time Frame: 12 weeks ]
  • Changes from baseline in main itching scores on patient diary [ Time Frame: 4 weeks ]
  • Changes from baseline in pruritus intensity scores assessed by investigator or subinvestigator [ Time Frame: week 2 and 4 ]
  • Pharmacokinetic parameters of fexofenadine at steady state; AUC [ Time Frame: week 4 and 12 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Atopic Dermatitis (AD)
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE Drug: fexofenadine/Allegra (M016455)

Pharmaceutical form:dry syrup formulation to be suspended in water

Route of administration: oral

Study Arms  ICMJE
  • Experimental: Age 6 months - 2 years
    Patients between 6 months and 2 years old - Type: Experimental
    Intervention: Drug: fexofenadine/Allegra (M016455)
  • Experimental: Age 2 - 11 years
    Patients between 2 and 11 years (and under 10.5 kg)
    Intervention: Drug: fexofenadine/Allegra (M016455)
  • Experimental: Age 2 - 11 years (and over 10.5 kg)
    Patients between 2 and 11 years (and over 10.5 kg)
    Intervention: Drug: fexofenadine/Allegra (M016455)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 17, 2010)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01244230
Other Study ID Numbers  ICMJE SFY10718
U1111-1115-4048 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP