Study Comparing SUBA™-Itraconazole With SPORANOX® (Itraconazole) in the Treatment of Onychomycosis (NCT00791219) | Clinical Trial Compass
CompletedPhase 2
Study Comparing SUBA™-Itraconazole With SPORANOX® (Itraconazole) in the Treatment of Onychomycosis
United States175 participantsStarted 2008-11
Plain-language summary
The objective of this study is to compare the relative efficacy and safety of SUBA™-Itraconazole Capsules (HalcyGen Ltd) to an already marketed oral formulation of itraconazole SPORANOX® (itraconazole) capsules (Janssen Pharma) in the treatment of onychomycosis of the toenail. Both the test and the reference formulations will also be compared to a placebo formulation to test for superiority.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or non-pregnant, non lactating females 18 years of age or older.
✓. Signed informed consent form, which meets all criteria of current FDA regulations.
✓. If female and of child bearing potential, have a negative urine pregnancy test at the baseline and randomization visits and prepared to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom with spermicide, inter-uterine device, oral, injected, transdermal or implanted hormonal contraceptives).
✓. Clinical diagnosis of onychomycosis of at least one great toenail
✓. Clinical signs and symptoms of onychomycosis of the most severely affected great toenail of at least moderate severity as defined by at least 25% but no more than 75% of the most infected toenail and a combined severity score of at least 4 using the Nail Infection Rating Scale (see Appendix A).
✓. At least 2mm of clear nail on the most affected toe between the proximal nail fold and the deepest extend of the onychomycosis.
✓. Positive potassium hydroxide (KOH) stain for confirmation of fungal nail infection
✓. Positive mycological culture for known fungal dermatophyte consistent with onychomycosis infection of at least one of the great toenails.
Exclusion criteria
✕. Females who are pregnant, lactating or likely to become pregnant during the study.
✕. Negative KOH stain
What they're measuring
1
Non-inferiority Will be Determined by Evaluating the Difference Between the Proportion of Patients in the Test and Reference Treatment Groups Who Are Considered a "Therapeutic Cure" at the End of Study Visit (Week 24)
Timeframe: Week 24
2
Non-inferiority Will be Determined by Evaluating the Difference Between the Proportion of Patients in the Test and Reference Treatment Groups Who Are Considered a "Clinical Cure" at the End of Study Visit (Week 24)
Timeframe: Week 24
3
Non-inferiority Will be Determined by Evaluating the Difference Between the Proportion of Patients in the Test and Reference Treatment Groups Who Are Considered a "Mycological Cure" at the End of Study Visit (Week 24)
. Negative mycological culture for fungal dermatophytes consistent with onychomycosis infection.
✕. Combined score of less than 4 on the Nail Infection Rating Scale for the most severely affected great toenail.
✕. Patient has superficial onychomycosis or significant dystrophy of the target toenail that in the Investigators opinion would impair the evaluation of onychomycosis.
✕. Patient has total dystrophic or proximal subungual onychomycosis of the target toenail.
✕. Presence of mycotic spikes or patient has exclusively lateral groove involvement of the target toenail.
✕. Less than 25% or more than 75% of the most severely infected great toenail affected.