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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01222299 | Safety, Pharmacokinetics, and Efficacy of Bepotastine Besilate Nasal Product After Ragweed Pollen Exposure in an Environmental Chamber | PHASE1 | COMPLETED | 89 | — | — | May 1, 2010 | Aug 1, 2010 | Oct 5, 2020 | 1 | United States |
Total nasal symptom scores (TNSS) was the summed scores for nasal pruritus \[itching\], rhinorrhea \[runny nose\], nasal congestion, and sneezing. Individual nasal symptoms were rated on a 4-point scale from 0-3 (0=Absent, 1=Mild, 2=Moderate, 3=Severe), with no half-unit assessments. TNSS was the sum score of 4 nasal symptoms with a maximum score for increased allergic response of 12 units. The minimum possible total score was 0.
| Arm | Type | Description |
|---|---|---|
| Arm 1 - Low Dose | EXPERIMENTAL | bepotastine besilate nasal product - low dose |
| Arm 2 - Medium Dose | EXPERIMENTAL | bepotastine besilate nasal product - medium dose |
| Arm 3 - High Dose | EXPERIMENTAL | bepotastine besilate nasal product - high dose |
| Arm 4 - Placebo | PLACEBO_COMPARATOR | placebo comparator nasal product |
| Name | Type | Description |
|---|---|---|
| bepotastine besilate nasal product - low dose | DRUG | sterile nasal product |
| bepotastine besilate nasal product - medium dose | DRUG | sterile nasal product |
| bepotastine besilate nasal product - high dose | DRUG | sterile nasal product |
| placebo comparator nasal product | DRUG | sterile nasal product |
Inclusion Criteria: * Subjects 18 to 65 years of age with a positive skin prick test with ragweed allergen Exclusion Criteria: * No active respiratory tract infection