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Study to Compare the Therapeutic Equivalence of Mometasone Furoate Nasal Spray, 50 mcg With Nasonex Nasal Spray in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis

NCT02125253 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 811

Last updated 2015-11-02

No results posted yet for this study

Summary

To evaluate the therapeutic equivalence of the lest formulation of Mometasone Furoate Nasal Spray, 50 mcg to the marketed formulation NASONEX® (mometasone furoate monohydrate) Nasal Spray, 50 mcg/actuation in patients with seasonal allergic rhinitis

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

Mometasone Furoate Nasal Spray, 50 mcg

a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate

DRUG

Nasonex Nasal Spray, 50 mcg

a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate monohydrate

DRUG

Placebo Nasal Spray

a metered-dose, manual pump spray unit containing an aqueous suspension

Sponsors & Collaborators

  • Novum Pharmaceutical Research Services

    collaborator INDUSTRY

  • Amneal Pharmaceuticals, LLC

    lead INDUSTRY

Principal Investigators

  • Keith Gallicano, PhD · Novum Pharmaceutical Reserach Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-03-31
Completion
2014-06-30

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 NCT02125253 on ClinicalTrials.gov