Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Perennial Allergic Rhinitis (PAR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01244217
First received: November 15, 2010
Last updated: October 12, 2013
Last verified: October 2013

November 15, 2010
October 12, 2013
October 2010
July 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01244217 on ClinicalTrials.gov Archive Site
  • 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 nasal symptom scores on patient diary [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in nasal symptom severity 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 ]
Same as current
Not Provided
Not Provided
 
Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Perennial Allergic Rhinitis (PAR)
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 Perennial Allergic Rhinitis

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

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.

Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Rhinitis Perennial
Drug: fexofenadine/Allegra (M016455)

Pharmaceutical form:dry syrup formulation to be suspended in water

Route of administration: oral

  • Experimental: Age 6 months - 2 years
    Patients between 6 months and 2 years old
    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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
August 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Aged 6 months through 11 years
  • Patients with perennial allergic rhinitis

Exclusion criteria:

  • Neither serum specific IgE antibody or skin reaction is positive for the antigen of perennial allergy.
  • Nasal symptom score is 0 for either sneezing or nasal discharge, or sum of these two score is less than 3, or nasal congestion score is 4.
  • Patients with vasomotor rhinitis or eosinophilic rhinitis.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Both
6 Months to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01244217
SFY10717, U1111-1115-3842
No
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
October 2013

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