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

Stiefel

Status and phase: Completed; Phase 3

Conditions: Onychomycosis

Treatments: Drug: Placebo tablets; Drug: Itraconazole 100mg capsules; Drug: Itraconazole 200mg tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00356915

BT0300-302-INT

Details and patient eligibility

About

Onychomycosis is a common condition accounting for approximately half of all nail disorders. It is most commonly caused by dermatophytes. Itraconazole has been approved for the treatment of onychomycosis in the United States with an approved dosage regimen for the treatment of onychomycosis of the toenail of once daily (QD) treatment with 200mg of itraconazole (two 100 mg capsules) for 12 weeks. Barrier Therapeutics has developed a 200 mg tablet which could be used in a more convenient one-tablet-per-day dosing regimen. This clinical trial will compare the efficacy and safety of this new tablet formulation with itraconazole capsules and placebo.

Full description

Onychomycosis is common and accounts for about half of all nail disorders. Usually the cause is due to dermatophytes, either Trichophyton rubrum (71%) or Trichophyton mentagrophytes (20%) but may also be due to yeast infection, usually Candida albicans.

The prevalence of onychomycosis in the United States population as a whole is 13% and is more prevalent in the elderly (60%). Onychomycosis of the toenail recurs and is thought to have a genetic component.

Onychomycosis can result in permanent nail deformity. This disease has a significant impact on the patient's quality of life (e.g., concern with the appearance of the toenails and fingernails, interference with wearing shoes, walking and sports activities).

Itraconazole has been approved for the treatment of onychomycosis in the United States since the mid-nineteen-nineties. The approved dosage regimen for treatment of onychomycosis of the toenail is once daily (QD) treatment with 200 mg of itraconazole (Sporanox®, Janssen Pharmaceutical Products, L.P., Titusville, NJ, USA) for 12 weeks. The approved dosage form is a 100mg capsule. Barrier Therapeutics has developed a 200mg tablet which could be used in a more convenient one-tablet-per-day dosing regimen.

This clinical trial will compare the efficacy and safety of this new tablet formulation with itraconazole capsules and placebo.

Enrollment: 1,381 patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of onychomycosis of at least one great toenail
• Percent Nail Involvement Score of the more severely affected great toenail (the Target Toenail) must be between 2 and 3 (25-75% of the nail unit).
• Length of Unaffected Part of the Target Toenail ≥2mm
• Direct microscopic examination with KOH that is positive for the hyphae associated with dermatophytes on the target toenail
• Subjects must have signed informed consent
• If the subject is woman of childbearing potential, she must have a negative urine pregnancy test and agree to use an effective form of birth control until the first menses after 60 days following the last dose of study medication.

Exclusion criteria

• Onychomycosis caused by Candida spp. without the presence of a dermatophyte
• Participation in a clinical trial for the systemic treatment of onychomycosis of the toenail within 24 weeks prior to Visit 1
• Use of systemic antifungals within 12 weeks prior to Visit 1
• Use of topical antifungal nail lacquer within 30 days prior to Visit 1
• Use of any other topical onychomycosis treatment on any toenail within 7 days prior to Visit 1
• Evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF
• Known liver disease or a history of liver toxicity with other drugs
• Use of systemic immunosuppressants

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,381 participants in 3 patient groups, including a placebo group

Itraconazole tablets

Experimental group

Description:

Itraconazole 200 mg tablets

Treatment:

Drug: Itraconazole 200mg tablets

Itraconazole capsules

Active Comparator group

Description:

Two Itraconazole 100 mg capsules were taken daily.

Treatment:

Drug: Itraconazole 100mg capsules

Placebo tablets

Placebo Comparator group

Description:

The itraconazole 200-mg tablets and placebo tablets exactly matched one another and were white to slightly grey in color, were oblong and biconvex in shape, and were melt-extrusion, film-coated.

Treatment:

Drug: Placebo tablets