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

NCT01244217 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2013-10-16

No results posted yet for this study

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

Conditions

  • Rhinitis Perennial

Interventions

DRUG

fexofenadine/Allegra (M016455)

Pharmaceutical form:dry syrup formulation to be suspended in water Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-07-31
Completion
2011-08-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01244217 on ClinicalTrials.gov