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A Comparison of Mometasone Nasal Spray, Nasonex Nasal Spray, Nasonex Nasal Spray Suspension, & Placebo for Treatment of Seasonal Allergies for Safety, Efficacy, & Superiority in 1520 Male & Female Volunteers

NCT02109185 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1307

Last updated 2014-04-09

No results posted yet for this study

Summary

The study will compare the safety and efficacy of a generic mometasone nasal spray to the reference listed drugs in the treatment of seasonal allergic rhinitis. Additionally both the test and the reference formulations will be tested for superiority against a placebo nasal spray.

Conditions

  • Treatment of the Signs and Symptoms of Seasonal Allergic Rhinitis

Interventions

DRUG

Mometasone Furoate Monohydrate Nasal Spray, 50 μg/act.

DRUG

Nasonex® Nasal Spray, 50 μg/actuation

DRUG

Nasonex® Nasal Spray Suspnsn, 50 μg/actuation

DRUG

Placebo Nasal Spray, 50 μL/actuation

Sponsors & Collaborators

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2013-10-31
Completion
2013-11-30

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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 NCT02109185 on ClinicalTrials.gov