OnychomycosisPhase 2NCT00791219

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

A Phase 2 study testing SUBA-itraconazole and Itraconazole in people with Onychomycosis, run by Halcygen Pharmaceuticals Limited at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Onychomycosis
What is being tested?: SUBA-itraconazole and Itraconazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 175 participants
Where: 8 sitesUnited States
Study dates: Nov 2008to Dec 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

Females who are pregnant, lactating or likely to become pregnant during the study.
Negative KOH stain
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.

Show all 23Show fewer

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.
Target toenail thickness is greater than 3mm.
No new nail growth in the target nail over the previous 6 months.
Onychomycosis not caused by a dermatophyte (e.g. mold infection, Candida spp or bacterial infection).
Previous treatment for onychomycosis of the toenail within the last 12 months that was unresponsive to treatment.
Previous treatment within the previous 2 months with any systemic antifungal therapy or within the previous 2 weeks with any topical antifungal therapy.
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.
Immunocompromised either because of concomitant disease (e.g. HIV), or ongoing treatment (e.g. chemotherapy).
Current or history of psoriasis within the previous 12 months.
Evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF.
History of diabetes.
Previous hypersensitivity to imidazole or azole compounds.
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.
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).
Receipt of any drug as part of a research study within 30 days prior to dosing.
Previous dosing in this study.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

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

Other trials in United States

About this study

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

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.

Conditions: Onychomycosis
Being tested: SUBA-itraconazole, Itraconazole, Placebo
Keywords: Onychomycosis
Medical subject headings: Onychomycosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SUBA-itraconazoleDrug
Also called itraconazole 50 mg capsules
100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)
ItraconazoleDrug
Also called Sporanox
200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
PlaceboDrug
Also called placebo capsules
Two placebo capsules taken approximately 30 minutes prior to breakfast

Study groups in NCT00791219
Study group	Role	What they receive
Test	Experimental	100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd) Receives: Drug: SUBA-itraconazole
Reference	Active comparator	200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma). Receives: Drug: Itraconazole
Placebo	Placebo comparator	Two placebo capsules taken approximately 30 minutes prior to breakfast Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Week 24
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
Measured: Week 24
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
Measured: Week 24

Secondary outcomes (3)

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
Measured: Week 12
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
Measured: week 12
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
Measured: week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2008Dec 2010

First posted14 Nov 2008 (estimated)
Study startNov 2008
Primary completionJul 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OnychomycosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 175 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00791219
Sponsor's protocol ID: 70850702
Other IDs: HGN06
Status last verified: Aug 2020
First submitted: 12 Nov 2008
Last updated: 25 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis
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All Onychomycosis trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00791219
Acronym / sponsor ID: 70850702
Conditions: Onychomycosis
Keywords: Onychomycosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 175 participants (actual)
Lead sponsor: Halcygen Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Jul 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 14 Nov 2008 (estimated)
Results: Posted 25 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Test	Experimental	Drug: SUBA-itraconazole100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)
Reference	Active comparator	Drug: Itraconazole200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
Placebo	Placebo comparator	Drug: PlaceboTwo placebo capsules taken approximately 30 minutes prior to breakfast

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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).

Key exclusion criteria (23 listed)

Females who are pregnant, lactating or likely to become pregnant during the study.
Negative KOH stain
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SUBA-itraconazoleAlso: itraconazole 50 mg capsules100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)	Drug	Test
ItraconazoleAlso: Sporanox200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).	Drug	Reference
PlaceboAlso: placebo capsulesTwo placebo capsules taken approximately 30 minutes prior to breakfast	Drug	Placebo

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)
Time frame: 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
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)
Time frame: 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
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)
Time frame: 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

3 secondary outcomes

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

Results and safety

Results posted to the registry on 25 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	24	19
Test	76	60
Reference	75	61

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)

Time frame: Week 24. Count of participants. Unit: Participants

Measure	Placebo n = 24	Test n = 76	Reference n = 74
Value	0	8	3

Test vs Reference: -20: 6.47
Placebo vs Test: p <0.05, one-sided continuity corrected Z-test

Population analysed: The Efficacy evaluation was performed on the intent to treat population, which included all patients that met all the following criteria; positive baseline mycological culture, dosed with the study drug at least once and had at least one post-baseline evaluation

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 "Clinical Cure" at the End of Study Visit (Week 24)

Time frame: Week 24. Count of participants. Unit: Participants

Measure	Placebo n = 24	Test n = 76	Reference n = 74
Value	0	12	4

Test vs Reference: -20: 10.38
Placebo vs Test: p <0.05, one-sided continuity corrected Z-test

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 "Mycological Cure" at the End of Study Visit (Week 24)

Time frame: Week 24. Count of participants. Unit: Participants

Measure	Placebo n = 24	Test n = 76	Reference n = 74
Value	1	25	22

Test vs Reference: -20: 3.17
Placebo vs Test: p <0.05, one-sided continuity corrected Z-test

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 24 (0%)	13 of 24 (54.2%)	0 of 24
Test	2 of 76 (2.6%)	42 of 76 (55.3%)	0 of 76
Reference	1 of 75 (1.3%)	35 of 75 (46.7%)	0 of 75

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Onychomycosis

RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
Not yet recruiting
Systemic Antifungal Plus Q-Switched Nd:YAG Laser for Onychomycosis
Onychomycosis
Active, not recruitingPhase 1
Photodynamic Therapy For Onychomycosis
Onychomycosis of Toenail
Recruiting
URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis
Onychomycosis of Toenail
Active, not recruiting
Exploring Different Dose-frequency Home Photodynamic Therapy Protocols Using a Novel Home-targeted LED Device for Onychomycosis
Onychomycosis of Toenails, Onychomycosis of Fingernail

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Roger Aston study chair

Halcygen Pharmaceuticals Limited

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SUBA-itraconazole and Itraconazole in people with Onychomycosis, run by Halcygen Pharmaceuticals Limited at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00791219.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020.