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A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Children With Perennial Allergic Rhinitis

NCT01018862 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 489

Last updated 2012-06-11

Study results available
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Summary

The purpose of this study is to compare the effectiveness of an Investigational use of an allergy medication (MP03-33) used to treat perennial allergic rhinitis (PAR) to placebo (a nasal spray that contains no medicine). In addition, the study will also compare the safety and effectiveness of an investigational use of another allergy medication (MP03-36) used to treat perennial allergic rhinitis to placebo.

Conditions

  • Perennial Allergic Rhinitis

Interventions

DRUG

Azelastine hydrochloride nasal spray 0.15%

822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks

DRUG

Azelastine hydrochloride nasal spray 0.10%

548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks

DRUG

Placebo

0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks

Sponsors & Collaborators

  • Meda Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • David Ginsberg, DO · Meda Phamaceuticals, Sr.Dir Medical and Scientific Affairs

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01018862 on ClinicalTrials.gov