Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00552110 | Study of Mometasone Furoate Nasal Spray and Oxymetazoline Nasal Spray Given Together Once A Day To Treat Seasonal Allergic Rhinitis (P04500) | PHASE2 | COMPLETED | 707 | — | — | Jul 1, 2007 | Feb 1, 2008 | May 14, 2024 | - | — |
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.
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.
| Arm | Type | Description |
|---|---|---|
| Combination1 | EXPERIMENTAL | Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily |
| Combination3 | EXPERIMENTAL | MFNS with OXY 3 sprays once daily |
| Mometasone | ACTIVE_COMPARATOR | MFNS once daily |
| Oxymetazoline | ACTIVE_COMPARATOR | OXY twice daily |
| Placebo | PLACEBO_COMPARATOR | Placebo nasal spray |
| Name | Type | Description |
|---|---|---|
| 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). |
| 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. |
| oxymetazoline nasal spray (OXY) twice daily | DRUG | OXY 2 sprays per nostril twice daily x 2 weeks. Matching placebo to MFNS given every morning. |
| Placebo | DRUG | Matching placebo to MFNS given every morning and every evening x 2 weeks. |
Inclusion Criteria: * Must be 12 years of age or older, of either sex, and of any race. * Must have at least a 2-year documented history of SAR which exacerbates during the time period over which the subject will be participating. * Must have a documented (within the past 12 months) positive skin-p...