NCT00791219

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Halcygen Pharmaceuticals Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Onychomycosis

Interventions

Type	Name	Description
DRUG	SUBA-itraconazole	100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)
DRUG	Itraconazole	200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
DRUG	Placebo	Two placebo capsules taken approximately 30 minutes prior to breakfast

Timeline

• Start date: 2008-11-01
• Primary completion: 2010-07-01
• Completion: 2010-12-01
• First posted: 2008-11-14
• Last updated: 2020-08-25
• Results posted: 2020-08-25

Locations

8 sites across 1 country: United States