A Blinded, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Compare the Therapeutic Equivalence of Mometasone Furoate Nasal Spray, 50 mcg (Amneal Pharmaceuticals LLC) With NASONEX® Nasal Spray (Schering Corporation) in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis

Amneal Pharmaceuticals, LLC10 sites in 1 country811 target enrollmentJanuary 2014

ConditionsSeasonal Allergic Rhinitis

InterventionsMometasone Furoate Nasal Spray, 50 mcg Nasonex Nasal Spray, 50 mcg Placebo Nasal Spray

DrugsMometasone Furoate Nasal Spray, 50 mcg Nasonex Nasal Spray, 50 mcg Placebo Nasal Spray

Overview

Phase: Phase 3
Intervention: Mometasone Furoate Nasal Spray, 50 mcg
Conditions: Seasonal Allergic Rhinitis
Sponsor: Amneal Pharmaceuticals, LLC
Enrollment: 811
Locations: 10
Primary Endpoint: Total Nasal Symptom Score (TNSS)
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

January 2014

End Date

June 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Amneal Pharmaceuticals, LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•If female and of child-bearing potential, have a negative urine pregnancy test and is prepared to abstain from sexual intercourse or use a reliable method of contraception during the study
•Documented positive allergic skin test, performed within the previous 12 months, to one or more of the allergens in season at the time the study is being conducted.
•A minimum of two consecutive years of previous history of seasonal allergic rhinitis to the pollen/allergen in season at the time the study is being conducted.
•A score of at least 6 on the reflective Total Nasal Symptom Score (rTNSS) and a minimum score of at least 2 for "nasal congestion" and a minimum score of at least 2 for one of the remaining 3 symptoms representing the 12hours prior to the screening visit.
•An average composite score of at least 6 on the rTNSS and a minimum score of at least 2 for "nasal congestion" and a minimum score of at least 2 for one of the remaining 3 symptoms representing the last 3 days of the 7-day placebo lead-in period before the randomization visit and the morning of the first day.
•of the randomization visit.

Exclusion Criteria

•Females who are pregnant, lactating or likely to become pregnant during the study.
•Negative or lack of documented skin allergen test (performed within the previous 12 months) to at least one of the allergens in season at the time the study is being conducted.
•Patients who suffer from chronic signs and symptoms of Perennial Allergic Rhinitis, unless the investigator assesses that the patient's current signs and symptoms are a clear exacerbation of Seasonal Allergic Rhinitis (SAR) rather than chronic PAR.
•Patients who suffer only from perennial allergic rhinitis or seasonal allergic rhinitis to a different allergen than that in season at the time the study is conducted.
•Previous history of less than 2 years of seasonal allergic rhinitis to the pollen/allergen in season at the time the study is being conducted.
•Any patient who meets the minimum rTNSS requirements at the start of the placebo lead-in period but no longer meets the requirements prior to the randomized active treatment period of the study cannot continue in the active treatment period.
•History of asthma over the previous two years that required chronic therapy. Occasional acute or mild exercise induced asthma will be allowable on the condition that the treatment of the attacks is restricted to beta-agonists only.
•Patients with nasal conditions, including infectious rhinitis, rhinitis medicamentosa or atrophic rhinitis.
•Clinically significant nasal deformity or any recent nasal surgery or trauma that has not completely healed.
•Sinus infection within the previous 30 days or history of reoccurring sinus infections.