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

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ClinicalTrials.gov Identifier: NCT00791219
Recruitment Status : Completed
First Posted : November 14, 2008
Last Update Posted : March 29, 2012
Sponsor:
Information provided by (Responsible Party):
Halcygen Pharmaceuticals Limited

Tracking Information
First Submitted Date  ICMJE November 12, 2008
First Posted Date  ICMJE November 14, 2008
Last Update Posted Date March 29, 2012
Study Start Date  ICMJE November 2008
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00791219 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Comparing SUBA™-Itraconazole With SPORANOX® (Itraconazole) in the Treatment of Onychomycosis
Official Title  ICMJE 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
Brief 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Onychomycosis
Intervention  ICMJE
  • 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
  • Drug: Itraconazole
    200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
    Other Name: Sporanox
  • Drug: Placebo
    Two placebo capsules taken approximately 30 minutes prior to breakfast
    Other Name: placebo capsules
Study Arms  ICMJE
  • Experimental: 1
    100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)
    Intervention: Drug: SUBA-itraconazole
  • Active Comparator: 2
    200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
    Intervention: Drug: Itraconazole
  • Placebo Comparator: 3
    Two placebo capsules taken approximately 30 minutes prior to breakfast
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 17, 2009)
175
Original Estimated Enrollment  ICMJE
 (submitted: November 12, 2008)
91
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00791219
Other Study ID Numbers  ICMJE 70850702
HGN06
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Halcygen Pharmaceuticals Limited
Study Sponsor  ICMJE Halcygen Pharmaceuticals Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Roger Aston Halcygen Pharmaceuticals Limited
PRS Account Halcygen Pharmaceuticals Limited
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP