Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail.
NCT ID: NCT00356915
Last Updated: 2017-02-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1381 participants
INTERVENTIONAL
2006-07-31
2008-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Itraconazole tablets
Itraconazole 200 mg tablets
Itraconazole 200mg tablets
Subjects took one 200mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit.
Itraconazole capsules
Two Itraconazole 100 mg capsules were taken daily.
Itraconazole 100mg capsules
Subjects took two 100mg capsules once per day after a full meal. The dose dose was taken the day before the Week 12 visit.
Placebo tablets
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.
Placebo tablets
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.
Interventions
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Itraconazole 100mg capsules
Subjects took two 100mg capsules once per day after a full meal. The dose dose was taken the day before the Week 12 visit.
Itraconazole 200mg tablets
Subjects took one 200mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit.
Placebo tablets
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
75 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Stiefel, a GSK Company
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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Radiant Research -Birmingham
Birmingham, Alabama, United States
University of Alabama School of Medicine
Birmingham, Alabama, United States
Radiant Research - Tucson
Tuscon, Arizona, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
East Bay Dermatology Medical Group Inc.
Fremont, California, United States
Skin Surgey Medical Group
San Diego, California, United States
Therapeutics Clinical Research
San Diego, California, United States
University of California
San Francisco, California, United States
Radiant Research - Santa Rosa
Santa Rosa, California, United States
Meridian Skincare
Englewood, Colorado, United States
The Savin Center
New Haven, Connecticut, United States
Dr. Stephen Horwitz
Aventure, Florida, United States
International Dermatology Research Inc.
Miami, Florida, United States
FMX Research Corporation
Miami, Florida, United States
Advanced Dermatology and Cosmetic Surgery
Ormond Beach, Florida, United States
Radiant Research - St. Petersburg
St. Petersburg, Florida, United States
Radiant Research - West Palm Beach
West Palm Beach, Florida, United States
Radiant Research - Atlanta West
Austell, Georgia, United States
Gwinnett Clinical Research Center Inc.
Snellville, Georgia, United States
Northwest Clinical Trials
Boise, Idaho, United States
Radiant Research - Chicago
Chicago, Illinois, United States
Radiant Research - Kansas City
Overland Park, Kansas, United States
Dr. David Fivenson
Ann Arbour, Michigan, United States
Skin and Vein Center
Troy, Michigan, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
VA Medical Center
Minneapolis, Minnesota, United States
Dr. Eduardo Tschen
Albuquerque, New Mexico, United States
Skin Specialty Group
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Dermatology Consulting Services
High Point, North Carolina, United States
Dermatology Clinical Research Center
Cincinnati, Ohio, United States
Radiant Research - Cincinnati
Cincinnati, Ohio, United States
Northwest Cutaneous Research
Portland, Oregon, United States
Oregon Medical Research Center
Portland, Oregon, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Radiant Research - Anderson
Anderson, South Carolina, United States
Radiant Research - Greenville
Greenville, South Carolina, United States
Dr. J. M. Humeniuk
Greer, South Carolina, United States
Dermatology East
Germantown, Tennessee, United States
Dermatology Associates of Knoxville
Knoxville, Tennessee, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
DermResearch Inc.
Austin, Texas, United States
Dr. Terry Jones
Bryan, Texas, United States
Radiant Research - Dallas North
Dallas, Texas, United States
Dr. Stephen Miller
San Antoinio, Texas, United States
Endeavor Clinical Trials
San Antonio, Texas, United States
Dermatology Research Center
Salt Lake City, Utah, United States
South Valley Dermatology Center
West Jordan, Utah, United States
Pariser Dermatology Specialists Ltd.
Norfolk, Virginia, United States
Radiant Research - Tacoma
Tacoma, Washington, United States
Madison Skin and Research Inc.
Madison, Wisconsin, United States
Advanced Healthcare S. C.
Milwaukee, Wisconsin, United States
Dr. Kirk Barber
Calgary, Alberta, Canada
Dr. Richard Thomas
Vancouver, British Columbia, Canada
Dr. Marc Bourcier
Moncton, New Brunswick, Canada
Dr. Aditja Gupta
London, Ontario, Canada
Dr. Chuck Lynde
Markham, Ontario, Canada
EntraLogix
Oakville, Ontario, Canada
Dr. Jerry Tan
Windsor, Ontario, Canada
Dr. Robert Bissonnette
Montreal, Quebec, 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
Countries
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References
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Maddin S, Quiring J, Bulger L. Randomized, placebo-controlled, phase 3 study of itraconazole for the treatment of onychomycosis. J Drugs Dermatol. 2013 Jul 1;12(7):758-63.
Other Identifiers
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BT0300-302-INT
Identifier Type: -
Identifier Source: org_study_id
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