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A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Seasonal Allergies

NCT01368445 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 617

Last updated 2011-10-06

No results posted yet for this study

Summary

The Purpose of this study is to evaluate the safety and efficacy of MP03-36 (0.15% azelastine hydrochloride)at dosages of 2 sprays per nostril once daily and 2 sprays per nostril twice daily in patients with seasonal allergic rhinitis.

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

azelastine hydrochloride 0.15% Nasal Spray

1644 mcg, 2 sprays per nostril twice daily AM \& PM)

DRUG

azelastine hydrochloride 0.15% and Placebo

822 mcg azelastine hydrochloride 0.15%, 2 sprays per nostril once daily (AM) and 0mg placebo spray 2 sprays per nostril once daily (PM)

DRUG

Azelastine 0.1%, Nasal Spray

1096 mcg, Azelastine 0.1%,2 sprays per nostril twice daily (AM \& PM)

Sponsors & Collaborators

  • Meda Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2006-11-30
Completion
2008-04-30

Countries

  • United States

Study Locations

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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 NCT01368445 on ClinicalTrials.gov