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A Study Comparing the Clinical Equivalence of Two Mometasone Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis

NCT01038427 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 795

Last updated 2021-02-03

Study results available
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Summary

This study compared the efficacy and safety of a generic mometasone nasal spray to the reference listed drug in the treatment of seasonal allergic rhinitis. Additionally both the test and the reference formulations were tested for superiority against a placebo nasal spray.

Conditions

  • Rhinitis, Allergic, Seasonal

Interventions

DRUG

Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals)

Mometasone nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.

DRUG

Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray

Mometasone nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.

DRUG

Placebo

Placebo nasal spray administered once daily (4 actuations) for 14 days.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-02
Primary Completion
2010-02-16
Completion
2010-02-16

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT01038427 on ClinicalTrials.gov