A Safety and Bioequivalence of a Mometasone Nasal Spray, 50 mcg/Actuation Compared With Nasonex® … (NCT01673659) | Clinical Trial Compass
CompletedPhase 3
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)
United States1,220 participantsStarted 2012-08
Plain-language 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.
Who can participate
Age range12 Years – 65 Years
SexALL
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Inclusion criteria
✓. Complete the informed consent/assent process.
✓. Male or female between 12-65 years of age.
✓. Female subjects of child-bearing potential must not be pregnant or nursing, must have a negative urine pregnancy test and abstain from sexual intercourse or use a reliable method of contraception during the study.
✓. Subjects will be eligible to participate if: a) Their total rTNSS is at least 6; b) Reflective rating for "nasal congestion/stuffy nose" is a score of \>2 at Visit 1; c) Reflective score of \>2 for at least one (1) of the remaining three (3) allergic rhinitis symptoms.
✓. A history (2 or more seasons) of seasonal allergy to at least one allergen known to be present during the study season, confirmed by a skin prick test. (A documented positive skin test within the previous 12 months is acceptable.)
Exclusion criteria
✕. Female who is pregnant or nursing, who is not using or does not agree to use an acceptable form of contraception during the study, or who intends to become pregnant during the study.
✕. Subject has a history of hypersensitivity or allergy to Mometasone, any other corticosteroids or any of the other study medication ingredients.
✕. Patients who suffer from chronic signs and symptoms of Perennial Allergic Rhinitis (PAR) should be excluded from the study, 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.
✕. A total score of less than 6 on the rTNSS or a score less than 2 for "nasal congestion" or a score less than 2 for all of the remaining 3 symptoms.
What they're measuring
1
Mean Change from Baseline for mean reflective Total Nasal Symptom Score (rTNSS)
✕. Subject has any condition or abnormality of the upper airway (ex: nasal polyps, obstruction, recent nasal surgery, structural abnormality, rhinitis medicamentosa, etc.) that, in the opinion of the Investigator, could interfere with administration of the product, evaluation of the subject's condition, or other aspect of the trial.
✕. Subject has experienced any upper respiratory tract infection or has experienced a sinus infection within the 30 days, or has a history of recurrent sinus infections i.e. acute or significant chronic sinusitis, preceding Visit 1.
✕. Subject has a history of asthma requiring chronic treatment within two years of study start.
✕. Subject lacks history of seasonal allergy to at least one allergen known to be present during the study season for at least the two preceding seasons.