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

A Phase III Randomized, Evaluator-Blind, Parallel Group Study of the Safety and Efficacy of Itraconazole Tablets, Itraconazole Capsules and Placebo in the Treatment of Onychomycosis of the Toenail.

Sponsors

Lead Sponsor: Stiefel, a GSK Company

Collaborator: GlaxoSmithKline

Source GlaxoSmithKline
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.

Overall Status Completed
Start Date July 2006
Completion Date October 2008
Primary Completion Date October 2008
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Clinical and Mycological Cure of Target Toenail 1 year
Complete Cure - Itraconazole Tablets Compared to Itraconazole Capsules 12 months
Secondary Outcome
Measure Time Frame
Clinical Improvement of the Target Toenail 12 months
Clinical Improvement Compared to Placebo 12 months
Enrollment 1381
Condition
Intervention

Intervention Type: Drug

Intervention Name: Itraconazole 100mg capsules

Description: Subjects took two 100mg capsules once per day after a full meal. The dose dose was taken the day before the Week 12 visit.

Arm Group Label: Itraconazole capsules

Other Name: Sporanox®

Intervention Type: Drug

Intervention Name: Itraconazole 200mg tablets

Description: Subjects took one 200mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit.

Arm Group Label: Itraconazole tablets

Other Name: Onmel

Intervention Type: Drug

Intervention Name: Placebo tablets

Description: 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.

Arm Group Label: Placebo tablets

Other Name: placebo

Eligibility

Criteria:

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

Gender: All

Minimum Age: 16 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
GSK Clinical Trials Study Director GlaxoSmithKline
Location
Facility:
Radiant Research -Birmingham | Birmingham, Alabama, 35209, United States
University of Alabama School of Medicine | Birmingham, Alabama, 35233, United States
Radiant Research - Tucson | Tuscon, Arizona, 85710, United States
Burke Pharmaceutical Research | Hot Springs, Arkansas, 71913, United States
East Bay Dermatology Medical Group Inc. | Fremont, California, 94538, United States
Skin Surgey Medical Group | San Diego, California, 92117, United States
Therapeutics Clinical Research | San Diego, California, 92123, United States
University of California | San Francisco, California, 94143-0517, United States
Radiant Research - Santa Rosa | Santa Rosa, California, 95405, United States
Meridian Skincare | Englewood, Colorado, 80112, United States
The Savin Center | New Haven, Connecticut, 06511, United States
Dr. Stephen Horwitz | Aventure, Florida, 33180, United States
International Dermatology Research Inc. | Miami, Florida, 33144, United States
FMX Research Corporation | Miami, Florida, 33175, United States
Advanced Dermatology and Cosmetic Surgery | Ormond Beach, Florida, 32174, United States
Radiant Research - St. Petersburg | St. Petersburg, Florida, 33781, United States
Radiant Research - West Palm Beach | West Palm Beach, Florida, 33407, United States
Radiant Research - Atlanta West | Austell, Georgia, 30106, United States
Gwinnett Clinical Research Center Inc. | Snellville, Georgia, 30078, United States
Northwest Clinical Trials | Boise, Idaho, 83704, United States
Radiant Research - Chicago | Chicago, Illinois, 60610, United States
Radiant Research - Kansas City | Overland Park, Kansas, 66215, United States
Dr. David Fivenson | Ann Arbour, Michigan, 48103, United States
Skin and Vein Center | Troy, Michigan, 48083, United States
Minnesota Clinical Study Center | Fridley, Minnesota, 55432, United States
VA Medical Center | Minneapolis, Minnesota, 55417, United States
Dr. Eduardo Tschen | Albuquerque, New Mexico, 87106, United States
Skin Specialty Group | New York, New York, 10021, United States
Columbia University Medical Center | New York, New York, 10032, United States
Dermatology Consulting Services | High Point, North Carolina, 27262, United States
Dermatology Clinical Research Center | Cincinnati, Ohio, 45219, United States
Radiant Research - Cincinnati | Cincinnati, Ohio, 45249, United States
Northwest Cutaneous Research | Portland, Oregon, 97210, United States
Oregon Medical Research Center | Portland, Oregon, 97223, United States
Rhode Island Hospital | Providence, Rhode Island, 02903, United States
Radiant Research - Anderson | Anderson, South Carolina, 29621, United States
Radiant Research - Greenville | Greenville, South Carolina, 29617, United States
Dr. J. M. Humeniuk | Greer, South Carolina, 29651, United States
Dermatology East | Germantown, Tennessee, 38138, United States
Dermatology Associates of Knoxville | Knoxville, Tennessee, 37917, United States
Tennessee Clinical Research Center | Nashville, Tennessee, 37215, United States
DermResearch Inc. | Austin, Texas, 78759, United States
Dr. Terry Jones | Bryan, Texas, 77802, United States
Radiant Research - Dallas North | Dallas, Texas, 75231, United States
Dr. Stephen Miller | San Antoinio, Texas, 78229, United States
Endeavor Clinical Trials | San Antonio, Texas, 78229, United States
Dermatology Research Center | Salt Lake City, Utah, 84124, United States
South Valley Dermatology Center | West Jordan, Utah, 84088, United States
Pariser Dermatology Specialists Ltd. | Norfolk, Virginia, 235507, United States
Radiant Research - Tacoma | Tacoma, Washington, 98499, United States
Madison Skin and Research Inc. | Madison, Wisconsin, 53719, United States
Advanced Healthcare S. C. | Milwaukee, Wisconsin, 53209, United States
Dr. Kirk Barber | Calgary, Alberta, T2S3B3, Canada
Dr. Richard Thomas | Vancouver, British Columbia, V5Z3Y1, Canada
Dr. Marc Bourcier | Moncton, New Brunswick, E1C8X3, Canada
Dr. Aditja Gupta | London, Ontario, N5X2P1, Canada
Dr. Chuck Lynde | Markham, Ontario, L3P7N8, Canada
EntraLogix | Oakville, Ontario, L6K1E1, Canada
Dr. Jerry Tan | Windsor, Ontario, N8W5L7, Canada
Dr. Robert Bissonnette | Montreal, Quebec, H2K4L5, Canada
Edifico Professional Guarionex Lopez | Santo Domingo, Dominican Republic
Dr. Manuel Briones | Guayaquil, Ecuador
Centro Orquidea Blanca | San Pedro, Sula, Honduras
Clinica Metropolis II | Panama City, Panama
Langeberg Medical Centre | Cape Town, South Africa
University of Cape Town | Cape Town, South Africa
Dr. Z. F. Ahmed Vawda | Durban, South Africa
DJW Navorsing | Krugerson, South Africa
Location Countries

Canada

Dominican Republic

Ecuador

Honduras

Panama

South Africa

United States

Verification Date

December 2016

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Itraconazole tablets

Type: Experimental

Description: Itraconazole 200 mg tablets

Label: Itraconazole capsules

Type: Active Comparator

Description: Two Itraconazole 100 mg capsules were taken daily.

Label: Placebo tablets

Type: Placebo Comparator

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.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Investigator)

Source: ClinicalTrials.gov