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
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: 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 July 20, 2014