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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00356915
Other study ID # BT0300-302-INT
Secondary ID
Status Completed
Phase Phase 3
First received July 25, 2006
Last updated May 18, 2015
Start date July 2006
Est. completion date October 2008

Study information

Verified date April 2015
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Canada: Health CanadaUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1381
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Onychomycosis
  • Onychomycosis, Toenail Onychomychosis, Toenail Fungus.

Intervention

Drug:
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.

Locations

Country Name City State
Canada Dr. Kirk Barber Calgary Alberta
Canada Dr. Aditja Gupta London Ontario
Canada Dr. Chuck Lynde Markham Ontario
Canada Dr. Marc Bourcier Moncton New Brunswick
Canada Dr. Robert Bissonnette Montreal Quebec
Canada EntraLogix Oakville Ontario
Canada Dr. Richard Thomas Vancouver British Columbia
Canada Dr. Jerry Tan Windsor Ontario
Dominican Republic Edifico Professional Guarionex Lopez Santo Domingo
Ecuador Dr. Manuel Briones Guayaquil
Honduras Centro Orquidea Blanca San Pedro Sula
Panama Clinica Metropolis II Panama City
South Africa 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
United States Dr. Eduardo Tschen Albuquerque New Mexico
United States Radiant Research - Anderson Anderson South Carolina
United States Dr. David Fivenson Ann Arbour Michigan
United States Radiant Research - Atlanta West Austell Georgia
United States DermResearch Inc. Austin Texas
United States Dr. Stephen Horwitz Aventure Florida
United States Radiant Research -Birmingham Birmingham Alabama
United States University of Alabama School of Medicine Birmingham Alabama
United States Northwest Clinical Trials Boise Idaho
United States Dr. Terry Jones Bryan Texas
United States Radiant Research - Chicago Chicago Illinois
United States Dermatology Clinical Research Center Cincinnati Ohio
United States Radiant Research - Cincinnati Cincinnati Ohio
United States Radiant Research - Dallas North Dallas Texas
United States Meridian Skincare Englewood Colorado
United States East Bay Dermatology Medical Group Inc. Fremont California
United States Minnesota Clinical Study Center Fridley Minnesota
United States Dermatology East Germantown Tennessee
United States Radiant Research - Greenville Greenville South Carolina
United States Dr. J. M. Humeniuk Greer South Carolina
United States Dermatology Consulting Services High Point North Carolina
United States Burke Pharmaceutical Research Hot Springs Arkansas
United States Dermatology Associates of Knoxville Knoxville Tennessee
United States Madison Skin and Research Inc. Madison Wisconsin
United States FMX Research Corporation Miami Florida
United States International Dermatology Research Inc. Miami Florida
United States Advanced Healthcare S. C. Milwaukee Wisconsin
United States VA Medical Center Minneapolis Minnesota
United States Tennessee Clinical Research Center Nashville Tennessee
United States The Savin Center New Haven Connecticut
United States Columbia University Medical Center New York New York
United States Skin Specialty Group New York New York
United States Pariser Dermatology Specialists Ltd. Norfolk Virginia
United States Advanced Dermatology and Cosmetic Surgery Ormond Beach Florida
United States Radiant Research - Kansas City Overland Park Kansas
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 Dermatology Research Center Salt Lake City Utah
United States Dr. Stephen Miller San Antoinio Texas
United States Endeavor Clinical Trials San Antonio Texas
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 Gwinnett Clinical Research Center Inc. Snellville Georgia
United States Radiant Research - St. Petersburg St. Petersburg Florida
United States Radiant Research - Tacoma Tacoma Washington
United States Skin and Vein Center Troy Michigan
United States Radiant Research - Tucson Tuscon Arizona
United States South Valley Dermatology Center West Jordan Utah
United States Radiant Research - West Palm Beach West Palm Beach Florida

Sponsors (2)

Lead Sponsor Collaborator
Stiefel, a GSK Company GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada,  Dominican Republic,  Ecuador,  Honduras,  Panama,  South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical and Mycological Cure of Target Toenail This study was designed to evaluate the superiority of itraconazole tablets to placebo tablets.
Clinical Cure was defined as an IGA score of 0 for the target toenail; Mycological Cure was defined as a negative potassium hydroxide (KOH) exam and a negative culture for dermatophytes of the target toenail.
1 year No
Primary Complete Cure - Itraconazole Tablets Compared to Itraconazole Capsules The primary efficacy endpoint was Compete Cure (consisting of a Clinical Cure and a Mycological Cure) at week 52. In this study, Clinical Cure was defined as an Investigator's Global Assessment (IGA) score of 0 for the target toenail; Mycological Cure was defined as a negative potassium hydroxide (KOH) examination and a negative culture outcome for dermatophytes of the target toenail. The efficacy analyses were conducted to demonstrate the non-inferiority of 1 itraconazole 200-mg tablet to 2 itraconazole 100-mg capsule. 12 months No
Secondary Clinical Improvement of the Target Toenail Clinical Improvement consisted of a mycological cure and an Investigator's Global Assessment (IGA) score less than or equal to 1 at week 52.
The Investigator's Global Assessment (IGA) assesses the overall severity of onychomycosis on the target toenail and takes into consideration, onycholysis, hyperkeratosis and percent nail involvement.
0 = Clinical Cure: No evidence of onychomycosis.
1 = Clinical Improvement: Minimal evidence of onychomycosis. 2 = Mild: =25% dystrophy and/or onycholysis. 3 = Moderate: =50% dystrophy with onycholysis. 4 = Severe: >50% dystrophy with onycholysis.
12 months No
Secondary Clinical Improvement Compared to Placebo Clinical Improvement consisted of a mycological cure and an Investigator's Global Assessment (IGA) score less than or equal to 1 at week 52.
The Investigator's Global Assessment(IGA)assesses the overall severity of onychomycosis on the target toenail and takes into consideration, onycholysis, hyperkeratosis and percent nail involvement.
0 = Clinical Cure: No evidence of onychomycosis.
1 = Clinical Improvement: Minimal evidence of onychomycosis. 2 = Mild: =25% dystrophy and/or onycholysis. 3 = Moderate: =50% dystrophy with onycholysis. 4 = Severe: >50% dystrophy with onycholysis.
12 months No