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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00491764 | A Study to Evaluate Efficacy and Safety of Four Posaconazole Regimens With Placebo and Terbinafine in the Treatment of Toenail Onychomycosis (Study P05082AM2)(COMPLETED) | PHASE2 | COMPLETED | 218 | — | — | Jun 1, 2007 | Dec 1, 2008 | Apr 7, 2017 | - | — |
Complete cure is defined as negative mycology (negative culture and KOH \[potassium hydroxide\]) and 0% nail involvement (defined as absence of onycholysis and subungual hyperkeratosis).
| Arm | Type | Description |
|---|---|---|
| Posaconazole 100 mg QD for 24 weeks. | EXPERIMENTAL | Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks. |
| Posaconazole 200 mg QD for 24 weeks. | EXPERIMENTAL | Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks. |
| Posaconazole 400 mg QD for 24 weeks. | EXPERIMENTAL | Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks. |
| Posaconazole 400 mg QD for 12 weeks. | EXPERIMENTAL | Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks. |
| Terbinafine | ACTIVE_COMPARATOR | Terbinafine 250 mg QD for 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Placebo for 24 weeks. |
| Name | Type | Description |
|---|---|---|
| SCH 56592 | DRUG | Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks. |
| Terbinafine | DRUG | Terbinafine 250 mg QD for 12 weeks. |
| Placebo | DRUG | Placebo for 24 weeks. |
Inclusion Criteria: * The subject must meet ALL the criteria listed below for entry: * Subject must be between 18 and 75 years of age inclusive, of either sex, and of any race; * Subject must have distal subungual infection that affects approximately 25% to 75% of at least one great toenail, b...