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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Tr

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 Summary: 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.
Sponsor: Halcygen Pharmaceuticals Limited

Current 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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: Same as current

Information By: Halcygen Pharmaceuticals Limited

Dates:
Date Received: November 12, 2008
Date Started: November 2008
Date Completion:
Last Updated: March 22, 2012
Last Verified: March 2012