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Study Comparing SUBA™-Itraconazole With SPORANOX® (Itraconazole) in the Treatment of Onychomycosis

This study has been completed.
Information provided by (Responsible Party):
Halcygen Pharmaceuticals Limited Identifier:
First received: November 12, 2008
Last updated: March 22, 2012
Last verified: March 2012
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.

Condition Intervention Phase
Onychomycosis Drug: SUBA-itraconazole Drug: Itraconazole Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Halcygen Pharmaceuticals Limited:

Primary Outcome Measures:
  • 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) [ Time Frame: Week 24 ]

Secondary Outcome Measures:
  • The proportion of patients in each treatment group who are considered a "therapeutic cure" at the End of Treatment Visit (Week 12). [ Time Frame: Week 12 ]

Enrollment: 175
Study Start Date: November 2008
Study Completion Date: December 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)
Drug: SUBA-itraconazole
100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)
Other Name: itraconazole 50 mg capsules
Active Comparator: 2
200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
Drug: Itraconazole
200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
Other Name: Sporanox
Placebo Comparator: 3
Two placebo capsules taken approximately 30 minutes prior to breakfast
Drug: Placebo
Two placebo capsules taken approximately 30 minutes prior to breakfast
Other Name: placebo capsules

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00791219

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Altamonte Springs, Florida, United States, 32701
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Miami, Florida, United States, 33175
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Boise, Idaho, United States, 83704
United States, North Carolina
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Salisbury, North Carolina, United States, 28144
United States, Oregon
Oregon Medical Research Center, P.C
Portland, Oregon, United States, 97223
United States, South Carolina
Coastal Carolina Research
Mt. Pleasant, South Carolina, United States, 29464
United States, Texas
JS Studies
College Station, Texas, United States, 77845
Endeavor Clinical Trials
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Halcygen Pharmaceuticals Limited
Study Chair: Roger Aston Halcygen Pharmaceuticals Limited
  More Information

Responsible Party: Halcygen Pharmaceuticals Limited Identifier: NCT00791219     History of Changes
Other Study ID Numbers: 70850702
Study First Received: November 12, 2008
Last Updated: March 22, 2012

Keywords provided by Halcygen Pharmaceuticals Limited:

Additional relevant MeSH terms:
Skin Diseases, Infectious
Nail Diseases
Skin Diseases
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors processed this record on September 25, 2017