Status:
COMPLETED
Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail.
Lead Sponsor:
Stiefel, a GSK Company
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Onychomycosis
Eligibility:
All Genders
16-75 years
Phase:
PHASE3
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 onychomyco...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
1381 Patients enrolled
Trial Details
Trial ID
NCT00356915
Start Date
July 1 2006
End Date
October 1 2008
Last Update
February 9 2017
Active Locations (68)
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1
Radiant Research -Birmingham
Birmingham, Alabama, United States, 35209
2
University of Alabama School of Medicine
Birmingham, Alabama, United States, 35233
3
Radiant Research - Tucson
Tuscon, Arizona, United States, 85710
4
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913