CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 175 enrolled
Drug / intervention
SUBA-itraconazole +2 moredrug
Likely dose
SUBA-itraconazole 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00791219
NCT00791219Phase 2Completed
CompareCT.gov

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

Halcygen Pharmaceuticals Limited·interventional·Posted Nov 14, 2008·Updated Aug 25, 2020

In Brief

A Phase 2 clinical trial evaluating SUBA-itraconazole, Itraconazole, and 1 other intervention for Onychomycosis. Completed, enrolled 175 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOnychomycosis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 14, 2008
Enrollment StartNov 1, 2008
Primary CompletionJul 1, 2010
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 17.6 years ago

Interventions

SUBA-itraconazoledrug

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

Itraconazoledrug

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

Placebodrug

Two placebo capsules taken approximately 30 minutes prior to breakfast