Clinical trial NCT00356915
Conditions: Onychomycosis
Keywords: Nail fungus Onychomycosis Itraconazole Toenail
Sponsor: Stiefel, a GSK Company
Start date: 2006-07-01; Completion date: 2008-10-01
Enrollment: 1381 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed 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.

Arms: arm 1: Itraconazole 200 mg tablets arm 2: Two Itraconazole 100 mg capsules were taken daily. arm 3: 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.
Interventions: intervention 1: Itraconazole 100mg capsules intervention 2: Itraconazole 200mg tablets intervention 3: Placebo tablets
Intervention descriptions: intervention 1: Subjects took two 100mg capsules once per day after a full meal. The dose dose was taken the day before the Week 12 visit. intervention 2: Subjects took one 200mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit. intervention 3: Placebo tablets are the same as the Itraconazole tablets but without the active drug included. Subjects took one tablet once per day after a full meal. The last tablet was taken the day before the Week 12 visit.

Protocol documents: