NCT00730405

Efficacy and Safety Study of 4 Dose Regimens of Oral Albaconazole in Subjects With Distal Subungual Onychomycosis

A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the Efficacy and Safety of 4 Dose Regimens of Oral Albaconazole in Subjects With Distal Subungual Onychomycosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 582 (actual)
• Sponsor: Stiefel, a GSK Company · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Phase 2 study to examine how the study drug works and its side effects in subjects with toenail fungus.

Detailed description

A phase 2, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to investigate the efficacy and safety of 4 dose regimens of ORAL albaconazole in subjects with distal subungual onychomycosis. Subjects will take oral study drug for up to 36 weeks and then will be followed for an additional 16 weeks to determine if the study drug was efficacious. Subjects will have routine blood draws and other safety assessments during the study, as well as regular assessments of their toenail fungus

Conditions

• Onychomycosis

Interventions

Type	Name	Description
DRUG	Albaconazole 100mg	Albaconazole for 36 weeks
DRUG	Albaconazole 200mg	Albaconazole for 36 weeks
DRUG	Albaconazole 400mg	Albaconazole for 36 weeks
DRUG	Albaconazole 400mg	Albaconazole for 24 weeks, Placebo for 12 weeks
DRUG	Placebo 400 mg	Placebo for 36 weeks

Timeline

• Start date: 2008-07-16
• Primary completion: 2010-02-19
• Completion: 2010-02-19
• First posted: 2008-08-08
• Last updated: 2018-03-12
• Results posted: 2018-02-07

Locations

33 sites across 3 countries: United States, Canada, Iceland