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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00730405 | Efficacy and Safety Study of 4 Dose Regimens of Oral Albaconazole in Subjects With Distal Subungual Onychomycosis | PHASE2 | COMPLETED | 582 | — | — | Jul 16, 2008 | Feb 19, 2010 | Mar 12, 2018 | 33 | United States, Canada +1 |
| NCT01039883 | A Study to Compare the Blood Levels of Albaconazole in Healthy Subjects Who Have Received a Single Dose of 400 mg Albaconazole as a Tablet Versus Albaconazole as a Capsule | PHASE1 | COMPLETED | 40 | — | — | Nov 23, 2009 | Jan 20, 2010 | Jun 22, 2017 | 1 | United States |
At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Effective treatment was defined as a mycological cure and clear or almost clear nail (distal subungual hyperkeratosis and/or onycholysis leaving less than 10% of nail plate effected). Comparisons were carried out in a sequential step-down fashion, combined with the Holm procedure at step 2. P-value was based on a sequential step-down combined with the Holm procedure. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52.
| Arm | Type | Description |
|---|---|---|
| Albaconazole 100mg | ACTIVE_COMPARATOR | Albaconazole for 36 weeks |
| Albaconazole 200mg | ACTIVE_COMPARATOR | Albaconazole for 36 weeks |
| Albaconazole 400mg | ACTIVE_COMPARATOR | Albaconazole for 36 weeks |
| Albaconazole 400mg 24 weeks, Placebo 12 weeks | ACTIVE_COMPARATOR | Albaconazole for 24 weeks, Placebo for 12 weeks |
| Placebo 400 mg | PLACEBO_COMPARATOR | Placebo for 36 weeks |
| 1 | EXPERIMENTAL | Subjects randomized to study product sequence 1 will receive the single albaconazole 400-mg tablet during the first dosing period and the four 100-mg albaconazole capsules during the second dosing period. |
| 2 | EXPERIMENTAL | Subjects randomized to study product sequence 2 will receive the four 100-mg albaconazole capsules during the first dosing period and the single albaconazole 400-mg tablet during the second dosing period. |
| Name | Type | Description |
|---|---|---|
| Albaconazole 100mg | DRUG | Albaconazole for 36 weeks |
| Albaconazole 200mg | DRUG | Albaconazole for 36 weeks |
| Albaconazole 400mg | DRUG | Albaconazole for 36 weeks |
| Placebo 400 mg | DRUG | Placebo for 36 weeks |
| Albaconazole tablet 400mg | DRUG | Albaconazole tablet 400mg single dose, then four albaconazole capsule 100mg single dose |
| Albaconazole 100mg capsules, then albaconazole 400mg tablet | DRUG | Four albaconazole capsule 100mg single dose, then albaconazole tablet 400mg single dose |
Inclusion Criteria: * Subject aged 18 to 75 years. * Diagnosis with distal subungual onychomycosis of the toenails that affects at least one great toe (target toenail). * Subject is willing to provide signed and dated written voluntary informed consent (and any local or national authorization requi...