CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 489 enrolled
Drug / intervention
Azelastine hydrochloride nasal spray 0.15% +2 moredrug
Likely dose
Azelastine hydrochloride nasal spray 0.15% 822 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01018862
NCT01018862Phase 3Completed
CompareCT.gov

Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 (0.15% Solution) and MP03-33 (0.10% Solution) in Children Ages >6 to <12 With Perennial Allergic Rhinitis

Meda Pharmaceuticals·interventional·Posted Nov 25, 2009·Updated Jun 11, 2012

In Brief

A Phase 3 clinical trial evaluating Azelastine hydrochloride nasal spray 0.15%, Azelastine hydrochloride nasal spray 0.10%, and 1 other intervention for Perennial Allergic Rhinitis. Completed, enrolled 489 participants across 39 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPerennial Allergic Rhinitis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 25, 2009
Enrollment StartNov 1, 2009
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 16.6 years ago

Interventions

Azelastine hydrochloride nasal spray 0.15%drug

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

Azelastine hydrochloride nasal spray 0.10%drug

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

Placebodrug

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