NCT00791219 - Study Comparing SUBA™-Itraconazole With SPORANOX® (Itraconazole) in the Treatment of Onychomycosis | Biotech Hunter

Enrollment

175

Participants

Timeline

Start Date

November 30, 2008

Primary Completion Date

July 31, 2010

Study Completion Date

December 31, 2010

Conditions

Onychomycosis

Interventions

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

Trial Locations (8)

PMG Research, Salisbury

Coastal Carolina Research, Mt. Pleasant

Synergyst Research, Altamonte Springs

FXM Research Corp, Miami

JS Studies, College Station

Endeavor Clinical Trials, San Antonio

Northwest Clinical Trials, Boise

Oregon Medical Research Center, P.C, Portland