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Clinical Equivalence Study of Mometasone Nasal Spray, 50 Mcg/Actuation

NCT01523236 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2012-02-01

No results posted yet for this study

Summary

The objective of this study is to evaluate the clinical equivalence of the test formulation of mometasone furoate anhydrous 50 mcg/actuation nasal spray (manufactured by Teva Pharmaceutical Industries, Ltd. and distributed by Teva Pharmaceuticals USA) to the marketed formulation Nasonex® (mometasone furoate monohydrate) nasal spray, 50 mcg/actuation (Schering) in patients with seasonal allergic rhinitis.

In addition, the efficacy of both the test and reference nasal sprays will be compared to a placebo nasal spray and safety will be compared.

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

Mometasone furoate

50 mcg/actuation Nasal Spray

DRUG

Nasonex®

50 mcg/actuation Nasal Spray

DRUG

Placebo

Nasal Spray

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-01-31
Completion
2012-01-31

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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 NCT01523236 on ClinicalTrials.gov