Conditions: Onychomycosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 218
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy, safety, and tolerability of oral administration of four dosing regimens of posaconazole relative to placebo and terbinafine, in the treatment of toenail onychomycosis.

Detailed description:

Arms:
arm 1: Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks. arm 2: Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks. arm 3: Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks. arm 4: Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks. arm 5: Terbinafine 250 mg QD for 12 weeks. arm 6: Placebo for 24 weeks.

Interventions: intervention 1: SCH 56592 intervention 2: SCH 56592 intervention 3: SCH 56592 intervention 4: SCH 56592 intervention 5: Terbinafine intervention 6: Placebo
Intervention descriptions: intervention 1: Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks. intervention 2: Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks. intervention 3: Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks. intervention 4: Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks. intervention 5: Terbinafine 250 mg QD for 12 weeks. intervention 6: Placebo for 24 weeks.

Protocol document: