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| Name | Class |
|---|---|
| Quintiles, Inc. | INDUSTRY |
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The primary objective of this study is to evaluate the efficacy of the combination of mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY) given together once a day in treating subjects with seasonal allergic rhinitis (SAR) in relieving symptoms including nasal congestion. The secondary objectives of this study are to evaluate the potential of the combination to produce tachyphylaxis and/or rebound congestion, and to evaluate the safety of the combination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination1 | Experimental | Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily |
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| Combination3 | Experimental | MFNS with OXY 3 sprays once daily |
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| Mometasone | Active Comparator | MFNS once daily |
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| Oxymetazoline | Active Comparator | OXY twice daily |
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| Placebo | Placebo Comparator | Placebo nasal spray |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY) | Drug | MFNS 2 sprays per nostril with OXY 1 spray per nostril once daily x 2 weeks. Matching placebo to MFNS given every evening (PM). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in AM/PM Instantaneous Total Nasal Symptom Score (NOW TNSS) Averaged Over Days 1 to 15 | Subjects scored severity of rhinorrhea, nasal congestion/stuffiness, nasal itching, and sneezing at the time of evaluation (NOW) using an ordinal scale from 0 = none to 3 = severe. Evaluations were performed daily in the morning (AM) and evening (PM). For each evaluation, individual symptom scores were summed to a TNSS, which was then averaged for a single score across the 15 day treatment period. | 15 days of treatment |
| Standardized Area Under the Curve From 0 to 4 Hours [AUC(0-4 hr)] of the Change From Baseline to Hour 4 on Day 1 in Nasal Congestion Score | Subjects scored nasal congestion/stuffiness using an ordinal scale from 0 = none to 3 = severe. Baseline was the average of the scores assessed every 15 minutes for 1 hour prior to dosing on Day 1. After dosing on Day 1, congestion was scored every 15 minutes for the 1st hour and every 30 minutes for the next 3 hours. Area under the curve (AUC) was calculated using the trapezoid rule, then standardization achieved by dividing the calculation by 4 hours. Treatment comparisons were examined using the standardized AUC(0-4 hr) of the change from baseline to hour 4 on Day 1. | from baseline to hour 4 on Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ariel A Teper, MD | Schering-Plough | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23562197 | Result | Meltzer EO, Bernstein DI, Prenner BM, Berger WE, Shekar T, Teper AA. Mometasone furoate nasal spray plus oxymetazoline nasal spray: short-term efficacy and safety in seasonal allergic rhinitis. Am J Rhinol Allergy. 2013 Mar-Apr;27(2):102-8. doi: 10.2500/ajra.2013.27.3864. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Combination1 | Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily |
| FG001 | Combination3 | MFNS with OXY 3 sprays once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY) | Drug | MFNS 2 sprays per nostril with OXY 3 sprays per nostril once daily x 2 weeks. Matching placebo to MFNS given every evening. |
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| mometasone furoate nasal spray (MFNS) once daily | Drug | MFNS 2 sprays per nostril once daily x 2 weeks. Matching placebo to MFNS given every morning (AM) and every evening. |
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| oxymetazoline nasal spray (OXY) twice daily | Drug | OXY 2 sprays per nostril twice daily x 2 weeks. Matching placebo to MFNS given every morning. |
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| Placebo | Drug | Matching placebo to MFNS given every morning and every evening x 2 weeks. |
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| FG002 | Mometasone | MFNS once daily |
| FG003 | Oxymetazoline | OXY twice daily |
| FG004 | Placebo | Placebo nasal spray |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Combination1 | Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily |
| BG001 | Combination3 | MFNS with OXY 3 sprays once daily |
| BG002 | Mometasone | MFNS once daily |
| BG003 | Oxymetazoline | OXY twice daily |
| BG004 | Placebo | Placebo nasal spray |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Intention to treat population: all randomized subjects who had taken at least one dose of study drug | Count of Participants | Participants |
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| Sex: Female, Male | Intention to treat population: all randomized subjects who had taken at least one dose of study drug | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in AM/PM Instantaneous Total Nasal Symptom Score (NOW TNSS) Averaged Over Days 1 to 15 | Subjects scored severity of rhinorrhea, nasal congestion/stuffiness, nasal itching, and sneezing at the time of evaluation (NOW) using an ordinal scale from 0 = none to 3 = severe. Evaluations were performed daily in the morning (AM) and evening (PM). For each evaluation, individual symptom scores were summed to a TNSS, which was then averaged for a single score across the 15 day treatment period. | Intention to treat (ITT): all randomized subjects who had taken at least one dose of study drug | Posted | Least Squares Mean | Standard Error | units on a scale | 15 days of treatment |
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| Primary | Standardized Area Under the Curve From 0 to 4 Hours [AUC(0-4 hr)] of the Change From Baseline to Hour 4 on Day 1 in Nasal Congestion Score | Subjects scored nasal congestion/stuffiness using an ordinal scale from 0 = none to 3 = severe. Baseline was the average of the scores assessed every 15 minutes for 1 hour prior to dosing on Day 1. After dosing on Day 1, congestion was scored every 15 minutes for the 1st hour and every 30 minutes for the next 3 hours. Area under the curve (AUC) was calculated using the trapezoid rule, then standardization achieved by dividing the calculation by 4 hours. Treatment comparisons were examined using the standardized AUC(0-4 hr) of the change from baseline to hour 4 on Day 1. | Intention to treat: all randomized subjects who had taken at least one dose of study drug | Posted | Least Squares Mean | Standard Error | units on a scale | from baseline to hour 4 on Day 1 |
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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 | Combination1 | Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily | 0 | 145 | 7 | 145 | ||
| EG001 | Combination3 | MFNS with OXY 3 sprays once daily | 0 | 139 | 5 | 139 | ||
| EG002 | Mometasone | MFNS once daily | 1 | 139 | 10 | 139 | ||
| EG003 | Oxymetazoline | OXY twice daily | 0 | 140 | 7 | 140 | ||
| EG004 | Placebo | Placebo nasal spray | 1 | 142 | 8 | 142 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | Systematic Assessment |
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| Oesophageal Haemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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Subject symptom data were not collected during the post-treatment period. Thus, daily diary data for rebound congestion was not analyzed.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Superiority or Other (legacy) |
| Null hypothesis: the concurrent administration of MFNS and OXY once daily has the same mean change from baseline in AM/PM NOW TNSS as that of OXY twice daily. | ANCOVA | <0.001 | 95 | Superiority or Other (legacy) |
| Null hypothesis: the administration of MFNS once daily has the same mean change from baseline in AM/PM NOW TNSS as that of placebo. | ANCOVA | <0.001 | 95 | Superiority or Other (legacy) |
| OG003 |
| Oxymetazoline |
OXY twice daily |
| OG004 | Placebo | Placebo nasal spray |
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