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CompletedNCT00791219Updated Aug 25, 2020Results posted

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

A Phase 2 interventional study of SUBA-itraconazole and Itraconazole in Onychomycosis, sponsored by Halcygen Pharmaceuticals Limited. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-25.

Sponsored by Halcygen Pharmaceuticals Limited · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
175
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Onychomycosis

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Keywords

  • Onychomycosis
03

In context

Onychomycosis

147 studies on the registry are indexed under Onychomycosis; 13 are open to participants now.

This study's enrollment of 175 is above the median of 56 across 134 interventional studies indexed under Onychomycosis.

Browse Onychomycosis studies →

Lead sponsor

This is the only study on the registry with Halcygen Pharmaceuticals Limited as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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, inter-uterine device, 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 potassium hydroxide (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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
175 participants (actual)

Study arms

  • Experimental
    Test

    100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)

    Drug: SUBA-itraconazole

  • Active comparator
    Reference

    200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).

    Drug: Itraconazole

  • Placebo comparator
    Placebo

    Two placebo capsules taken approximately 30 minutes prior to breakfast

    Drug: Placebo

Interventions

  • DrugSUBA-itraconazole

    100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)

    Also known as: itraconazole 50 mg capsules

  • DrugItraconazole

    200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).

    Also known as: Sporanox

  • DrugPlacebo

    Two placebo capsules taken approximately 30 minutes prior to breakfast

    Also known as: placebo capsules

06

What researchers measure

Primary outcomes

  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)

    If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure at Visit 7 was greater than 20 then non-inferiority was considered to have been demonstrated

    Time frame: 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)

    If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Clinical Cure at Visit 7 was greater than 20 then non-inferiority was considered to have been demonstrated

    Time frame: 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)

    If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Mycological Cure at Visit 7 was greater than 20 then non-inferiority was considered to have been demonstrated

    Time frame: Week 24

Secondary outcomes

  1. The Proportion of Patients in Each Treatment Group Who Are Considered a "Therapeutic Cure" at the End of Treatment Visit (Week 12) 12).

    If the lower bound 95% confidence interval of the difference between the proportion of patients in the test group compared to the reference group considered a cure at the visit being analyzed was greater than -20 then non-inferiority was considered to have been demonstrated

    Time frame: Week 12

  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 12)

    If the lower bound 95% confidence interval of the difference between the proportion of patients in the test group compared to the reference group considered a cure at the visit being analyzed was greater than -20 then non-inferiority was considered to have been demonstrated

    Time frame: week 12

  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 12)

    If the lower bound 95% confidence interval of the difference between the proportion of patients in the test group compared to the reference group considered a cure at the visit being analyzed was greater than -20 then non-inferiority was considered to have been demonstrated

    Time frame: week 12

Other outcomes

  1. Superiority of Test Treatment Over Placebo for Mycological Cure

    All primary and secondary endpoints were tested for superiority against Placebo. The intent to treat (ITT) was used for all superiority testing. For the three primary endpoints and all four dichotomous secondary endpoints, if the difference between the proportion of patients considered a cure in the Test or Reference group was statistically greater (p \< 0.05) than the proportion of patients considered a cure in the Placebo group, then superiority of that treatment over placebo was considered to have been demonstrated. A one-sided continuity corrected Z-test was used for superiority testing.

    Time frame: week 6

07

Results

Posted Aug 25, 2020
Limitations and caveats
Subjects were followed for 12 weeks after the 12 week treatment period, typically subjects would be followed for at least 24 weeks post-treatment to allow sufficient time for the nail to grow out and therefore maximizing rates of clinical cure

Participant flow

Participant flow — Overall Study
MilestonePlaceboTestReference
Started247675
Completed196061
Not completed51614

Outcome measures

PrimaryNon-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)

If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure at Visit 7 was greater than 20 then non-inferiority was considered to have been demonstrated

Time frame:
Week 24
Reported as:
Count of participants · Participants
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)
ParticipantsPlaceboTestReference
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)083
Statistical analysis
  • Test vs Reference · -20: 6.47
  • Placebo vs Test · one-sided continuity corrected Z-test · p = <0.05
PrimaryNon-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)

If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Clinical Cure at Visit 7 was greater than 20 then non-inferiority was considered to have been demonstrated

Time frame:
Week 24
Reported as:
Count of participants · Participants
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)
ParticipantsPlaceboTestReference
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)0124
Statistical analysis
  • Test vs Reference · -20: 10.38
  • Placebo vs Test · one-sided continuity corrected Z-test · p = <0.05
PrimaryNon-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)

If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Mycological Cure at Visit 7 was greater than 20 then non-inferiority was considered to have been demonstrated

Time frame:
Week 24
Reported as:
Count of participants · Participants
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)
ParticipantsPlaceboTestReference
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)12522
Statistical analysis
  • Test vs Reference · -20: 3.17
  • Placebo vs Test · one-sided continuity corrected Z-test · p = <0.05
SecondaryThe Proportion of Patients in Each Treatment Group Who Are Considered a "Therapeutic Cure" at the End of Treatment Visit (Week 12) 12).

If the lower bound 95% confidence interval of the difference between the proportion of patients in the test group compared to the reference group considered a cure at the visit being analyzed was greater than -20 then non-inferiority was considered to have been demonstrated

Time frame:
Week 12
Reported as:
Count of participants · Participants
The Proportion of Patients in Each Treatment Group Who Are Considered a "Therapeutic Cure" at the End of Treatment Visit (Week 12) 12).
ParticipantsPlaceboTestReference
The Proportion of Patients in Each Treatment Group Who Are Considered a "Therapeutic Cure" at the End of Treatment Visit (Week 12) 12).000
SecondaryNon-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 12)

If the lower bound 95% confidence interval of the difference between the proportion of patients in the test group compared to the reference group considered a cure at the visit being analyzed was greater than -20 then non-inferiority was considered to have been demonstrated

Time frame:
week 12
Reported as:
Count of participants · Participants
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 12)
ParticipantsPlaceboTestReference
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 12)010
SecondaryNon-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 12)

If the lower bound 95% confidence interval of the difference between the proportion of patients in the test group compared to the reference group considered a cure at the visit being analyzed was greater than -20 then non-inferiority was considered to have been demonstrated

Time frame:
week 12
Reported as:
Count of participants · Participants
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 12)
ParticipantsPlaceboTestReference
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 12)31616
Statistical analysis
  • Test vs Reference · -20: -0.57
Other pre-specifiedSuperiority of Test Treatment Over Placebo for Mycological Cure

All primary and secondary endpoints were tested for superiority against Placebo. The intent to treat (ITT) was used for all superiority testing. For the three primary endpoints and all four dichotomous secondary endpoints, if the difference between the proportion of patients considered a cure in the Test or Reference group was statistically greater (p \< 0.05) than the proportion of patients considered a cure in the Placebo group, then superiority of that treatment over placebo was considered to have been demonstrated. A one-sided continuity corrected Z-test was used for superiority testing.

Time frame:
week 6
Reported as:
Count of participants · Participants
Superiority of Test Treatment Over Placebo for Mycological Cure
ParticipantsPlaceboTestReference
Superiority of Test Treatment Over Placebo for Mycological Cure0115
Statistical analysis
  • Placebo vs Test · A one-sided continuity corrected Z-test · p = <0.05 (It the difference between the proportion of patients considered a cure was statistically greater (p\<0.05) than the proportion of patients considered a cure in the Placebo group, then superiority was considered to have been demonstrated.) · Mean difference (final values): 0.0018
  • Placebo vs Reference · A one-sided continuity corrected Z-test · p = <0.05 · Median difference (final values): 0.0853

Adverse events

Collected over The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/24 (0%)0/24 (0%)13/24 (54.2%)
Test0/76 (0%)2/76 (2.6%)42/76 (55.3%)
Reference0/75 (0%)1/75 (1.3%)35/75 (46.7%)
Most frequent serious events
Most frequent serious events
EventPlaceboTestReference
Lumbar Spinal StenosisMusculoskeletal and connective tissue disorders0/240/761/75
Pulmonary EmbolismVascular disorders0/241/760/75
Intervertebral disc protusionMusculoskeletal and connective tissue disorders0/241/760/75
Most frequent other events
Showing 10 of 31
Most frequent other events
EventPlaceboTestReference
HeadacheNervous system disorders2/247/768/75
NasopharyngitisRespiratory, thoracic and mediastinal disorders2/247/765/75
Pain in ExtremityMusculoskeletal and connective tissue disorders1/242/764/75
Arthropod BiteInjury, poisoning and procedural complications1/240/760/75
Back PainMusculoskeletal and connective tissue disorders1/241/761/75
Depressed MoodPsychiatric disorders1/240/760/75
DermatitisSkin and subcutaneous tissue disorders1/240/760/75
Dermatitis ContactSkin and subcutaneous tissue disorders1/240/760/75
DizzinessNervous system disorders1/241/760/75
Erectile DysfunctionReproductive system and breast disorders1/240/760/75

Baseline characteristics

Age, Continuous
Age, Continuous(years of age)PlaceboTestReferenceTotal
Mean50.29 (21 to 73)47.41 (23 to 73)48.64 (21 to 78)48.78 (21 to 78)
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboTestReferenceTotal
Female4252049
Male205155126
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboTestReferenceTotal
American Indian or Alaska Native0000
Asian1001
Native Hawaiian or Other Pacific Islander0101
Black or African American2169
White217469164
More than one race0000
Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(participants)PlaceboTestReferenceTotal
United States247675175
Percentage of toe infected
Percentage of toe infected(percentage)PlaceboTestReferenceTotal
Mean61.42 ± 15.9955.08 ± 15.7058.32 ± 14.9958.27 ± 15.56
Infecting organism - T.rubrum
Infecting organism - T.rubrum(participants)PlaceboTestReferenceTotal
Number247269165
Presence of infecting organism - T.mentagrophytes
Presence of infecting organism - T.mentagrophytes(participants)PlaceboTestReferenceTotal
Number0369
08

Study locations

8 sites
  • Synergyst Research
    Altamonte Springs, Florida 32701, United States
  • FXM Research Corp
    Miami, Florida 33175, United States
  • Northwest Clinical Trials
    Boise, Idaho 83704, United States
  • PMG Research
    Salisbury, North Carolina 28144, United States
  • Oregon Medical Research Center, P.C
    Portland, Oregon 97223, United States
  • Coastal Carolina Research
    Mount Pleasant, South Carolina 29464, United States
  • JS Studies
    College Station, Texas 77845, United States
  • Endeavor Clinical Trials
    San Antonio, Texas 78229, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00791219
Lead sponsor
Halcygen Pharmaceuticals Limited
Responsible party
Sponsor
First posted
Nov 14, 2008
Start date
Nov 2008
Primary completion
Jul 2010
Completion
Dec 2010
Results posted
Aug 25, 2020
Last update
Aug 25, 2020

Study contacts

Roger Aston
study chair · Halcygen Pharmaceuticals Limited

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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