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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00127647 | An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327) | PHASE3 | COMPLETED | 1,375 | — | — | Nov 1, 2004 | Apr 1, 2005 | Aug 15, 2024 | - | — |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | montelukast sodium 5 mg, QD 2-weeks |
| 2 | EXPERIMENTAL | montelukast sodium 10 mg QD 2-weeks |
| 3 | ACTIVE_COMPARATOR | Pranlukast 225 mg BID 2-weeks |
| Name | Type | Description |
|---|---|---|
| montelukast sodium | DRUG | montelukast sodium; 5 mg, 10 mg QD 2-weeks. |
| Comparator: pranlukast | DRUG | Pranlukast 225 mg BID 2-weeks. |
Inclusion Criteria: * Japanese males and females with a 2-year documented history of seasonal allergic rhinitis symptoms and positive allergy testing (cedar, alder and/or cypress) Exclusion Criteria: * Patients with drug-induced rhinitis or non-allergic rhinitis, or patients who used anti-histami...