A Phase 2 interventional study of Placebo and Mometasone furoate in Rhinitis, Allergic, Perennial, sponsored by Organon and Co. Completed. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-08-15.
Sponsored by Organon and Co · Phase 2, Interventional, and Treatment
This is a multicenter, randomized, double-blind within the dose level, parallel group comparison of mometasone furoate nasal spray in subjects with perennial allergic rhinitis to examine the minimal effective dose, the recommended dose, and the dosing regimen.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 455 is above the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients of mongoloid race residing in Japan who satisfy all of the following criteria:
Exclusion Criteria:
Patients who meet any of the following exclusion criteria are not included in the present study:
The placebo group was divided into 3 groups receiving 1, 2 or 4 sprays/nostril. The regimen of each placebo group was BID
Drug: Placebo
Drug: Placebo · Drug: Mometasone furoate
Drug: Placebo · Drug: Mometasone furoate
Drug: Placebo · Drug: Mometasone furoate
Drug: Mometasone furoate
Drug: Mometasone furoate
One, two, or four sprays of placebo are administered to the left and right nostrils twice a day (in the morning and at night) for 2 weeks.
One spray of mometasone furoate 50 mcg is administered to the left and right nostrils in the morning, and one spray of placebo to the left and right nostrils at night for 2 weeks. The daily dose of mometasone furoate is 100 mcg.
Also known as: Nasonex, SCH 32088
Two sprays of mometasone furoate 50 mcg are administered to the left and right nostrils in the morning, and two sprays of placebo to the left and right at night for 2 weeks. The daily dose of mometasone furoate is 200 mcg.
Also known as: Nasonex, SCH 32088
Four sprays of mometasone furoate 50 mcg are administered to the left and right nostrils in the morning, and four sprays of placebo to the left and right nostrils at night for 2 weeks. The daily dose of mometasone furoate is 400 mcg.
Also known as: Nasonex, SCH 32088
One spray of mometasone furoate 50 mcg is administered to the left and right nostrils twice a day (in the morning and at night) for 2 weeks. The daily dose of mometasone furoate is 200 mcg.
Also known as: Nasonex, SCH 32088
Two sprays of mometasone furoate 50 mcg are administered to the left and right nostrils twice a day (in the morning and at night) for 2 weeks. The daily dose of mometasone furoate is 400 mcg.
Also known as: Nasonex, SCH 32088
Change in 4 nasal symptom score (sneezing attack, rhinorrhea, nasal congestion, and nasal itching) from baseline at Week 2
Time frame: After 2 weeks of treatment
Change in each nasal symptom (sneezing attack, rhinorrhea, nasal congestion, and nasal itching)
Time frame: After 1 and 2 weeks of treatment
Overall improvement
Time frame: After 1 and 2 weeks of treatment
QOL score
Time frame: At initial day of treatment and after 2 weeks of treatment
Adverse events
Time frame: From initial day of treatment until 7-10 days after treatment is stopped.
Laboratory tests
Time frame: From initial day of treatment until treatment is stopped.
No study locations are listed for this record.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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