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This study will evaluate the effectiveness and safety of MFNS in improving nasal congestion/obstruction and in reducing bilateral nasal polyps.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | Experimental | Participants receive mometasone furoate nasal spray (MFNS) 200 mcg twice daily (BID) for 16 weeks |
|
| Placebo | Placebo Comparator | Participants receive matching placebo nasal spray BID for 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | Drug | MFNS, 200 mcg BID administered as two 50 mcg sprays in each nostril BID for up to 16 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Congestion/Obstruction Score | At Baseline, the Investigator and participant jointly evaluated the signs and symptoms of congestion/obstruction. After Baseline, participants scored the signs and symptoms of congestion/obstruction every morning immediately prior to dosing using a morning instantaneous congestion/obstruction score. This score reflected the participant's condition at that time (instantaneous) and ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3= severe), with a lower score indicating less congestion/obstruction. Congestion/obstruction scores were averaged over Weeks 1-4 of the treatment period. Data are compared using Least Square (LS) Means. LS Mean Change from Baseline = LS Mean Score averaged over Weeks 1-4 - LS Mean Score for Baseline. | Baseline and Weeks 1-4 |
| Change From Baseline in Total Polyp Size Score | An endoscopic nasal examination was performed by the Investigator. Bilateral nasal polyps were scored as follows for each notril (left and right): 0=no polyps, 1=polyps in middle meatus not reaching below inferior border of middle turbinate, 2=polyps reaching below inferior border of middle turbinate but not inferior border of inferior turbinate, 3=large polyps reaching to or below the lower borders of the inferior turbinate or polyps medial to the middle turbinate. Total polyp size score ranged from 0 to 6 (scored 0 to 3 for each nostril), with a lower score indicating smaller-sized polyps. LS Mean Change from Baseline = LS Mean Score for Week 16 - LS Mean Score for Baseline. | Baseline and Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26575524 | Result | Zhou B, He G, Liang J, Cheng L, Mehta A, Liu S, Yu W, Wang Z, Han D. Mometasone furoate nasal spray in the treatment of nasal polyposis in Chinese patients: a double-blind, randomized, placebo-controlled trial. Int Forum Allergy Rhinol. 2016 Jan;6(1):88-94. doi: 10.1002/alr.21650. Epub 2015 Nov 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mometasone Furoate Nasal Spray (MFNS) | Participants receive mometasone furoate nasal spray (MFNS) 200 mcg twice daily (BID) for 16 weeks |
| FG001 | Placebo | Participants receive matching placebo nasal spray BID for 16 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MFNS | Participants receive MFNS 200 mcg BID for 16 weeks |
| BG001 | Placebo | Participants receive matching placebo nasal spray BID for 16 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Congestion/Obstruction Score | At Baseline, the Investigator and participant jointly evaluated the signs and symptoms of congestion/obstruction. After Baseline, participants scored the signs and symptoms of congestion/obstruction every morning immediately prior to dosing using a morning instantaneous congestion/obstruction score. This score reflected the participant's condition at that time (instantaneous) and ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3= severe), with a lower score indicating less congestion/obstruction. Congestion/obstruction scores were averaged over Weeks 1-4 of the treatment period. Data are compared using Least Square (LS) Means. LS Mean Change from Baseline = LS Mean Score averaged over Weeks 1-4 - LS Mean Score for Baseline. | The Full Analysis Set (FAS) population consisted of all randomized participants who received at least one dose of study treatment and who had a baseline and at least one post-baseline efficacy assessment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Weeks 1-4 |
|
Up to approximately 20 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MFNS | Participants receive MFNS 200 mcg BID for 16 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular extrasystoles | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D009298 | Nasal Polyps |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
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| Placebo for MFNS | Drug | Two sprays in each nostril BID for up to 16 weeks |
|
| Protocol Violation |
|
| Disease Progress |
|
| Withdrawal by Subject |
|
| Adverse Event |
|
| Lack of Efficacy |
|
| Participant Leaving Country |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 | MFNS | Participants receive MFNS 200 mcg BID for 16 weeks |
| OG001 | Placebo | Participants receive matching placebo nasal spray BID for 16 weeks |
|
|
|
| Primary | Change From Baseline in Total Polyp Size Score | An endoscopic nasal examination was performed by the Investigator. Bilateral nasal polyps were scored as follows for each notril (left and right): 0=no polyps, 1=polyps in middle meatus not reaching below inferior border of middle turbinate, 2=polyps reaching below inferior border of middle turbinate but not inferior border of inferior turbinate, 3=large polyps reaching to or below the lower borders of the inferior turbinate or polyps medial to the middle turbinate. Total polyp size score ranged from 0 to 6 (scored 0 to 3 for each nostril), with a lower score indicating smaller-sized polyps. LS Mean Change from Baseline = LS Mean Score for Week 16 - LS Mean Score for Baseline. | The FAS population consisted of all randomized participants who received at least one dose of study treatment and who had a baseline and at least one post-baseline efficacy assessment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 16 |
|
|
|
|
| 2 |
| 375 |
| 0 |
| 375 |
| EG001 | Placebo | Participants receive matching placebo nasal spray BID for 16 weeks | 3 | 373 | 0 | 373 |
| Fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nasal polypectomy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
The Investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial.
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |