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
  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
Rhinitis Perennial
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 Perennial Allergic Rhinitis

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 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 ]

Enrollment: 100
Study Start Date: October 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
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 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244217

Locations
Japan
Sanofi-Aventis Investigational Site Number 392015
Fukuoka-Shi, Japan
Sanofi-Aventis Investigational Site Number 392012
Kanazawa-Shi, Japan
Sanofi-Aventis Investigational Site Number 392001
Kawaguchi-Shi, Japan
Sanofi-Aventis Investigational Site Number 392004
Kawasaki-Shi, Japan
Sanofi-Aventis Investigational Site Number 392003
Kawasaki-Shi, Japan
Sanofi-Aventis Investigational Site Number 392002
Kita-Ku, Japan
Sanofi-Aventis Investigational Site Number 392011
Kofu-Shi, Japan
Sanofi-Aventis Investigational Site Number 392014
Obu-Shi, Japan
Sanofi-Aventis Investigational Site Number 392013
Seki-Shi, Japan
Sanofi-Aventis Investigational Site Number 392005
Yokohama-Shi, Japan
Sanofi-Aventis Investigational Site Number 392006
Yokohama-Shi, Japan
Sanofi-Aventis Investigational Site Number 392007
Yokohama-Shi, Japan
Sanofi-Aventis Investigational Site Number 392009
Yokohama-Shi, Japan
Sanofi-Aventis Investigational Site Number 392010
Yokohama-Shi, Japan
Sanofi-Aventis Investigational Site Number 392008
Yokohama-Shi, Japan
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01244217     History of Changes
Other Study ID Numbers: SFY10717, U1111-1115-3842
Study First Received: November 15, 2010
Last Updated: October 12, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
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 17, 2014