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A Safety and Bioequivalence of a Mometasone Nasal Spray, 50 mcg/Actuation Compared With Nasonex® Nasal Spray 50 mcg/Actuation in the Relief of the Symptoms of Seasonal Allergic Rhinitis (SAR)

NCT01673659 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1220

Last updated 2021-10-22

No results posted yet for this study

Summary

The objectives of this study is to demonstrate bioequivalence (comparable safety and efficacy) of the Test product to the Reference in the treatment of subjects seasonal allergic rhinitis.

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

Mometasone furoate

DRUG

Nasonex Nasal Spray

DRUG

Placebo nasal spray

Sponsors & Collaborators

  • Padagis LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2012-10-31
Completion
2012-10-31

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 NCT01673659 on ClinicalTrials.gov