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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00751075 | Effectiveness and Safety of Once or Twice Daily Mometasone Nasal Spray Versus Amoxicillin Versus Placebo for Treatment of Acute Rhinosinusitis (Phase 3 Study)(Study P02692) | PHASE3 | COMPLETED | 981 | — | — | Dec 1, 2003 | Jun 22, 2004 | Aug 15, 2024 | - | — |
| NCT00750750 | Effectiveness and Safety of Once or Twice Daily Mometasone Nasal Spray Versus Amoxicillin Versus Placebo for Treatment of Acute Rhinosinusitis (Study P02683) | PHASE2 | COMPLETED | 981 | — | — | Jan 1, 2003 | Sep 1, 2003 | Aug 15, 2024 | - | — |
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | MFNS once daily |
| 2 | EXPERIMENTAL | MFNS twice daily |
| 3 | ACTIVE_COMPARATOR | Amoxicillin |
| 4 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| mometasone furoate nasal spray (MFNS) | DRUG | Placebo capsules three times daily for 10 days, and MFNS 50 mcg/spray, 2 sprays in each nostril once daily in the morning and placebo nasal spray once daily in the evening for 15 days, followed by 14-day no-treatment observation period |
| MFNS | DRUG | Placebo capsules three times daily for 10 days, and MFNS 50 mcg/spray, 2 sprays in each nostril twice daily for 15 days followed by 14-day no-treatment observation period |
| Amoxicillin | DRUG | Amoxicillin 500 mg/capsule, one capsule 3 times a day for 10 days and placebo nasal spray twice daily for 15 days, followed by a 14-day no-treatment observation period |
| Placebo | DRUG | Placebo capsule three times daily for 10 days and placebo nasal spray twice daily for 15 days, followed by 14-day no-treatment observation |
Inclusion Criteria: Subjects must: * have been diagnosed with acute rhinosinusitis * have had signs and symptoms of rhinosinusitis for at least 7 but not more than 28 days prior to Baseline * have had a major symptom score \>=5 and \<=12 at the Screening and Baseline, and no more than 3 of the 5 m...