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Sponsored by: |
Stiefel Laboratories |
Information provided by: | Stiefel Laboratories |
ClinicalTrials.gov Identifier: | NCT00730405 |
Phase 2 study to examine how the study drug works and its side effects in subjects with toenail fungus.
Condition | Intervention | Phase |
Toenail Fungus Onychomycosis Distal, Subungual Onychomycosis |
Drug: W0027 Drug: Placebo |
Phase II |
MedlinePlus related topics: | Molds |
Drug Information available for: | Albaconazole |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Investigate the Efficacy and Safety of 4 Dose Regimens of Oral Albaconazole in Subjects With Distal Subungual Onychomycosis |
Estimated Enrollment: | 550 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
W0027 for 9 months
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Drug: W0027
W0027 for 36 weeks
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2: Active Comparator
W0027 for 9 months
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Drug: W0027
W0027 for 36 weeks
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3: Active Comparator
W0027 for 9 months
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Drug: W0027
W0027 for 36 weeks
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4: Active Comparator
W0027 for 6 months, Placebo for 3 months
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Drug: W0027
W0027 for 24 weeks, Placebo for 12 weeks
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5: Placebo Comparator
Placebo for 9 months
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Drug: Placebo
Placebo for 36 weeks
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A phase 2, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to investigate the efficacy and safety of 4 dose regimens of ORAL albaconazole in subjects with distal subungual onychomycosis. Subjects will take oral study drug for up to 36 weeks and then will be followed for an additional 16 weeks to determine if the study drug was efficacious. Subjects will have routine blood draws and other safety assessments during the study, as well as regular assessments of their toenail fungus
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subjects with any of the following conditions or characteristics will be excluded from study enrollment (ie, will not receive study product):
Show 31 Study Locations |
Stiefel Laboratories |
Study Director: | David A Angulo, MD | Stiefel Labortories, Inc. |
Responsible Party: | Stiefel Laboratories, Inc. ( Jason Mann/Director, Global Clinical Operations ) |
Study ID Numbers: | W0027-10 |
First Received: | August 4, 2008 |
Last Updated: | October 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00730405 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Iceland: Icelandic Medicines Control Agency |
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