Itraconazole Tablets vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail

Condition:

Onychomycosis (nail fungus) of the toenail

Name of study:

Itraconazole Tablets vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail

Sponsor:

Barrier Therapeutics Inc.

Status:

Recruiting

Treatment:

Itraconazole capsules (Sporanox®)
Itraconazole tablets (investigational medication)

Phase:

3

Study Design:

Randomized, Single Blind, Placebo Control, Safety and Efficacy Study

Expected Total Enrollment:

1268

Eligibility:

age 16-75 years

Main Inclusion Criteria:

• Clinical diagnosis of onychomycosis of at least one great toenail
• Fungal infection must cover between 25-75% of the target toenail
• Fungal infection must be confirmed by both microscope and mycology sample testing
• Women of childbearing potential must not be pregnant and agree to use an effective form of birth control during treatment and for 60 days after the last dose of study medication.

Main Exclusion Criteria:

• Use of oral antifungals within 12 weeks prior to visit one.
• Use of topical antifungal nail liqueur within 30 days prior to visit one.
• History of congestive heart failure.
• Liver disease
• Use of medications that are prohibited with Sporanox® treatment