Study Comparing SUBA™-Itraconazole With SPORANOX® (Itraconazole) in the Treatment of Onychomycosis
Information source: Halcygen Pharmaceuticals Limited
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Onychomycosis
Intervention: SUBA-itraconazole (Drug); Itraconazole (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Halcygen Pharmaceuticals Limited Official(s) and/or principal investigator(s):
Roger Aston, Study Chair, Affiliation: Halcygen Pharmaceuticals Limited
Overall contact:
Aimee L Brown, Phone: (412) 363-3300, Ext: 609, Email: ABrown@novumprs.com
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.
Clinical Details
Official title: A Randomized, Double Blind, Multiple-Site, Placebo-Controlled Study, Comparing the Efficacy and Safety of SUBA™-Itraconazole Capsules Compared to SPORANOX® (Itraconazole) Capsules in the Treatment of Onychomycosis of the Toenail
Study design: Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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)
Secondary outcome: The proportion of patients in each treatment group who are
considered a "therapeutic cure" at the End of Treatment Visit (Week
12).
Detailed description:
Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel designed study
comparing a dosing regimen of 100 mg approximately 30 minutes prior to breakfast for 12
weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd) to the approved dosing regimen of
200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
Patients will be randomly assigned in a 3: 3:1 ratio to the test product 100 mg once-a-day:
reference product 200 mg once-a-day: placebo once-a-day. respectively. The patients will
complete 5 visits: baseline/screening (within 28 days of randomization), Day 1
(randomization), Week 6, Week 12 and Week 24.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Male or non-pregnant, non lactating females 18 years of age or older.
2. Signed informed consent form, which meets all criteria of current FDA regulations.
3. 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, IUD, oral, injected, transdermal or implanted hormonal contraceptives).
4. Clinical diagnosis of onychomycosis of at least one great toenail
5. 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).
6. At least 2mm of clear nail on the most affected toe between the proximal nail fold
and the deepest extend of the onychomycosis.
7. Positive KOH stain for confirmation of fungal nail infection
8. Positive mycological culture for known fungal dermatophyte consistent with
onychomycosis infection of at least one of the great toenails.
Exclusion Criteria:
1. Females who are pregnant, lactating or likely to become pregnant during the study.
2. Negative KOH stain
3. Negative mycological culture for fungal dermatophytes consistent with onychomycosis
infection.
4. Combined score of less than 4 on the Nail Infection Rating Scale for the most
severely affected great toenail.
5. Patient has superficial onychomycosis or significant dystrophy of the target toenail
that in the Investigators opinion would impair the evaluation of onychomycosis.
6. Patient has total dystrophic or proximal subungual onychomycosis of the target
toenail.
7. Presence of mycotic spikes or patient has exclusively lateral groove involvement of
the target toenail.
8. Less than 25% or more than 75% of the most severely infected great toenail affected.
9. Target toenail thickness is greater than 3mm.
10. No new nail growth in the target nail over the previous 6 months.
11. Onychomycosis not caused by a dermatophyte (e. g. mold infection, Candida spp or
bacterial infection).
12. Previous treatment for onychomycosis of the toenail within the last 12 months that
was unresponsive to treatment.
13. Previous treatment within the previous 2 months with any systemic antifungal therapy
or within the previous 2 weeks with any topical antifungal therapy.
14. Significant history or current evidence of chronic infectious disease, system
disorder, organ disorder or other medical condition that in the Investigator's
opinion would place the study patient at undue risk by participation or could
jeopardize the integrity of the study evaluations.
15. Immunocompromised either because of concomitant disease (e. g. HIV), or ongoing
treatment (e. g. chemotherapy).
16. Current or history of psoriasis within the previous 12 months.
17. Evidence of ventricular dysfunction such as congestive heart failure (CHF) or a
history of CHF.
18. History of diabetes.
19. Previous hypersensitivity to imidazole or azole compounds.
20. Liver Function Test results at screening more than twice the upper limit of normal
range or other hematology or clinical chemistry test results that would
contraindicate dosing with itraconazole.
21. Use within the previous 3 months or anticipated use during the study of any drugs
that are known to affect the bioavailability of oral itraconazole or are otherwise
contraindicated to be taken with itraconazole as detailed in the product labeling for
SPORANOX® (Appendix B).
22. Receipt of any drug as part of a research study within 30 days prior to dosing.
23. Previous dosing in this study.
Locations and Contacts
Aimee L Brown, Phone: (412) 363-3300, Ext: 609, Email: ABrown@novumprs.com
FXM Research Corp, Miami, Florida 33175, United States; Recruiting
Hector Wiltz, Principal Investigator
Northwest Clinical Trials, Boise, Idaho 83704, United States; Recruiting
Brock McConnehey, Principal Investigator
Oregon Medical Research Center, P.C, Portland, Oregon 97223, United States; Recruiting
Robert Matheson, Principal Investigator
Coastal Carolina Research, Mt. Pleasant, South Carolina 29464, United States; Recruiting
Cynthia Strout, Principal Investigator
Additional Information
Starting date: November 2008
Ending date: July 2010
Last updated: March 18, 2009
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