Efficacy and Safety Study of 4 Dose Regimens of Oral Albaconazole in Subjects With Distal Subungu… (NCT00730405) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety Study of 4 Dose Regimens of Oral Albaconazole in Subjects With Distal Subungual Onychomycosis
United States582 participantsStarted 2008-07-16
Plain-language summary
Phase 2 study to examine how the study drug works and its side effects in subjects with toenail fungus.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject aged 18 to 75 years.
* Diagnosis with distal subungual onychomycosis of the toenails that affects at least one great toe (target toenail).
* Subject is willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures are performed.
* Subject is able to complete the study, comply with study instructions, and take study product orally.
* Sexually active non-lactating females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product and up to the first menses 60 days following the last dose of study product.
* Women of childbearing potential must have a negative pregnancy test at enrollment.
* Subject has screening laboratory parameters and ECG within the normal ranges unless considered to be not clinically relevant by the principal investigator.
Exclusion Criteria:
Subjects with any of the following conditions or characteristics will be excluded from study enrollment (ie, will not receive study product):
* Subject has received an investigational drug within 4 weeks of the first dose of study product, or who are scheduled to receive an investigational drug other than the study product during the study.
* Subject has participated in a clinical trial for the systemic treatment of onychomycosis of the toenails within 6 months prior to the first dose…
What they're measuring
1
The Percentage of Participants Who Achieve Effective Treatment at Week 52