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Sponsored by: |
Halcygen Pharmaceuticals Limited |
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Information provided by: | Halcygen Pharmaceuticals Limited |
ClinicalTrials.gov Identifier: | NCT00791219 |
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.
Condition | Intervention | Phase |
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Onychomycosis |
Drug: SUBA-itraconazole Drug: Itraconazole Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
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 Treatment of Onychomycosis of the Toenail |
Estimated Enrollment: | 91 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)
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Drug: SUBA-itraconazole
100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)
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2: Active Comparator
200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
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Drug: Itraconazole
200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
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3: Placebo Comparator
Two placebo capsules taken approximately 30 minutes prior to breakfast
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Drug: Placebo
Two placebo capsules taken approximately 30 minutes prior to breakfast
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Aimee L Brown | (412) 363-3300 ext 609 | ABrown@novumprs.com |
Contact: Gail D Gongas | (412) 363-3300 | GDGongas@novumprs.com |
United States, Florida | |
FXM Research Corp | |
Miami, Florida, United States, 33175 | |
United States, Idaho | |
Northwest Clinical Trials | |
Boise, Idaho, United States, 83704 | |
United States, Oregon | |
Oregon Medical Research Center, P.C | |
Portland, Oregon, United States, 97223 | |
United States, South Carolina | |
Coastal Carolina Research | |
Mt. Pleasant, South Carolina, United States, 29464 |
Study Chair: | Roger Aston | Halcygen Pharmaceuticals Limited |
Responsible Party: | Halcygen Pharmaceuticals Limited ( Roger Aston ) |
Study ID Numbers: | 70850702, HGN06 |
Study First Received: | November 12, 2008 |
Last Updated: | November 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00791219 |
Health Authority: | United States: Food and Drug Administration |
Onychomycosis |
Mycoses Skin Diseases, Infectious Onychomycosis Skin Diseases Clotrimazole Miconazole |
Tioconazole Hydroxyitraconazole Itraconazole Tinea Dermatomycoses |
Anti-Infective Agents Antiparasitic Agents Antiprotozoal Agents Nail Diseases |
Therapeutic Uses Antifungal Agents Infection Pharmacologic Actions |