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

NCT00791219 | Completed Phase 2 Results

• 2 other identifiers: 70850702HGN06
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 8

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.

Conditions

Onychomycosis

Keywords

Onychomycosis

Outcome Measures

Primary Outcomes (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 "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

  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

  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

  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).

  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)

  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)

  week 12

Other Outcomes (1)

• Superiority of Test Treatment Over Placebo for Mycological Cure

  week 6

Study Arms (3)

Test

EXPERIMENTAL

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

Drug: SUBA-itraconazole

Reference

ACTIVE COMPARATOR

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

Drug: Itraconazole

Placebo

PLACEBO COMPARATOR

Two placebo capsules taken approximately 30 minutes prior to breakfast

Drug: Placebo

Interventions

SUBA-itraconazole DRUG

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

Test

Itraconazole DRUG

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

Also known as: Sporanox

Reference

Placebo DRUG

Two placebo capsules taken approximately 30 minutes prior to breakfast

Also known as: placebo capsules

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Halcygen Pharmaceuticals Limited: lead

Study Sites (8)

Synergyst Research

Altamonte Springs, Florida, 32701, United States

Location

FXM Research Corp

Miami, Florida, 33175, United States

Location

Northwest Clinical Trials

Boise, Idaho, 83704, United States

Location

PMG Research

Salisbury, North Carolina, 28144, United States

Location

Oregon Medical Research Center, P.C

Portland, Oregon, 97223, United States

Location

Coastal Carolina Research

Mt. Pleasant, South Carolina, 29464, United States

Location

JS Studies

College Station, Texas, 77845, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Onychomycosis

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

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

Results Point of Contact

• Title: Stuart Mudge, VP Scientific Affairs
• Organization: Mayne Pharma

stuart.mudge@maynepharma.com

+613 8614 7704

Study Officials

• Roger Aston

  Halcygen Pharmaceuticals Limited

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2008
• First Posted: November 14, 2008
• Study Start: November 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 25, 2020
• Results First Posted: August 25, 2020

Record last verified: 2020-08

Locations

US (8)