Last updated: 11/07/2018 16:00:38
Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail.
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:
Clinical and Mycological Cure of Target Toenail
Timeframe: 1 year
Complete Cure - Itraconazole tablets compared to Itraconazole capsules
Timeframe: 12 months
Secondary outcomes:
Clinical improvement of the target toenail
Timeframe: 12 months
Clinical improvement compared to placebo
Timeframe: 12 months
Interventions:
Drug: Itraconazole 100mg capsules
Drug: Itraconazole 200mg tablets
Drug: Placebo tablets
Enrollment:
1381
Observational study model:
Not applicable
Primary completion date:
2008-31-10
Time perspective:
Not applicable
Clinical publications:
Maddin S, Quiring J, Bulger L. Randomized, Placebo-controlled, Phase 3 Study of Itraconazole for the Treatment of Onychomycosis. J Drugs Dermatol . 2013;12(7):758-763.
Medical condition
onychomycosis
Product
itraconazole
Collaborators
GSK
Study date(s)
July 2006 to October 2008
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
16 - 75 years
Accepts healthy volunteers
No
- 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).
- 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
Inclusion and exclusion 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
Trial location(s)
Location
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
Status
Study Complete
Location
South Valley Dermatology Center
West Jordan, UT, United States, 84088
Status
Study Complete
Location
Radiant Research - West Palm Beach
West Palm Beach, FL, United States, 33407
Status
Study Complete
Location
Radiant Research - Chicago
Chicago, Illinois, United States, 60610
Status
Study Complete
Location
Columbia University Medical Center
New York, New York, United States, 10032
Status
Study Complete
Location
Therapeutics Clinical Research
San Diego, CA, United States, 92123
Status
Study Complete
Location
East Bay Dermatology Medical Group Inc.
Fremont, CA, United States, 94538
Status
Study Complete
Location
Radiant Research - Greenville
Greenville, SC, United States, 29617
Status
Study Complete
Location
Advanced Dermatology and Cosmetic Surgery
Ormond Beach, Florida, United States, 32174
Status
Study Complete
Location
Radiant Research - Santa Rosa
Santa Rosa, CA, United States, 95405
Status
Study Complete
Location
Radiant Research - Cincinnati
Cincinnati, Ohio, United States, 45249
Status
Study Complete
Location
Oregon Medical Research Center
Portland, OR, United States, 97223
Status
Study Complete
Location
Northwest Cutaneous Research
Portland, OR, United States, 97210
Status
Study Complete
Location
Endeavor Clinical Trials
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
Madison Skin and Research Inc.
Madison, WI, United States, 53719
Status
Study Complete
Location
Radiant Research - Atlanta West
Austell, GA, United States, 30106
Status
Study Complete
Location
Radiant Research - Kansas City
Overland Park, KS, United States, 66215
Status
Study Complete
Location
Pariser Dermatology Specialists Ltd.
Norfolk, VA, United States, 235507
Status
Study Complete
Location
Dermatology Clinical Research Center
Cincinnati, Ohio, United States, 45219
Status
Study Complete
Location
University of California
San Francisco, California, United States, 94143-0517
Status
Study Complete
Location
Tennessee Clinical Research Center
Nashville, TN, United States, 37215
Status
Study Complete
Location
Radiant Research - Anderson
Anderson, South Carolina, United States, 29621
Status
Study Complete
Location
Gwinnett Clinical Research Center Inc.
Snellville, GA, United States, 30078
Status
Study Complete
Location
University of Alabama School of Medicine
Birmingham, Alabama, United States, 35233
Status
Study Complete
Location
Dermatology Research Center
Salt Lake City, Utah, United States, 84124
Status
Study Complete
Location
Dermatology Consulting Services
High Point, NC, United States, 27262
Status
Study Complete
Location
Skin Surgey Medical Group
San Diego, California, United States, 92117
Status
Study Complete
Location
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Status
Study Complete
Location
Dermatology Associates of Knoxville
Knoxville, TN, United States, 37917
Status
Study Complete
Location
Radiant Research - St. Petersburg
St. Petersburg, FL, United States, 33781
Status
Study Complete
Location
Radiant Research -Birmingham
Birmingham, AL, United States, 35209
Status
Study Complete
Location
Edifico Professional Guarionex Lopez
Santo Domingo, Dominican Republic
Status
Study Complete
Location
International Dermatology Research Inc.
Miami, FL, United States, 33144
Status
Study Complete
Location
Minnesota Clinical Study Center
Fridley, MN, United States, 55432
Status
Study Complete
Location
Radiant Research - Dallas North
Dallas, TX, United States, 75231
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2008-31-10
Actual study completion date
2008-31-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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