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

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:

Drug Information available for: Fexofenadine Fexofenadine hydrochloride

U.S. FDA Resources

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 ]

Estimated 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, 814-0114
Sanofi-Aventis Investigational Site Number 392012
Kanazawa-Shi, Japan, 921-8154
Sanofi-Aventis Investigational Site Number 392001
Kawaguchi-Shi, Japan, 333-0861
Sanofi-Aventis Investigational Site Number 392004
Kawasaki-Shi, Japan, 212-0027
Sanofi-Aventis Investigational Site Number 392003
Kawasaki-Shi, Japan, 216-0002
Sanofi-Aventis Investigational Site Number 392002
Kita-Ku, Japan, 114-0023
Sanofi-Aventis Investigational Site Number 392011
Kofu-Shi, Japan, 921-8801
Sanofi-Aventis Investigational Site Number 392014
Obu-Shi, Japan, 474-0073
Sanofi-Aventis Investigational Site Number 392013
Seki-Shi, Japan, 501-3247
Sanofi-Aventis Investigational Site Number 392005
Yokohama-Shi, Japan, 224-0037
Sanofi-Aventis Investigational Site Number 392006
Yokohama-Shi, Japan, 224-0003
Sanofi-Aventis Investigational Site Number 392007
Yokohama-Shi, Japan, 222-0011
Sanofi-Aventis Investigational Site Number 392009
Yokohama-Shi, Japan, 226-0018
Sanofi-Aventis Investigational Site Number 392010
Yokohama-Shi, Japan, 232-0056
Sanofi-Aventis Investigational Site Number 392008
Yokohama-Shi, Japan, 240-0044

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:	September 13, 2011
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 June 17, 2013