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Last Updated: November 15, 2019

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CLINICAL TRIALS PROFILE FOR NIZORAL A-D

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505(b)(2) Clinical Trials for Nizoral A-d

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT01110330 An Efficacy Study of a New Formulation of Ketoconazole 2% Cream in Patients With Tinea Pedis, Commonly Known as Athlete's Foot Terminated Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Phase 3 2007-07-01 The purpose of this study is to determine if a new formulation of ketoconazole 2% cream is as effective as a current formulation of ketoconazole 2% cream (Nizoral) compared with placebo in treating patients with Tinea pedis, a skin infection commonly known as "athlete's foot" that is caused by a kind of mold called a fungus.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Nizoral A-d

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00129207 Ketoconazole Administration: How it is Affected by the Body and Broken Down and How it Acts on the Body When Used With Velcade Completed Millennium Pharmaceuticals, Inc. Phase 1 1969-12-31 The purpose of this study is to investigate how ketoconazole (Nizoral) affects the pharmacokinetics (how the study drug is affected by the body and broken down) and pharmacodynamics (how the study drug acts on the body) of the active ingredient in the study drug Velcade (bortezomib).
NCT00388596 A Study Of SB-751689, Atorvastatin, Ketoconazole, And Rosuvastatin In Health Postmenopausal Women. Completed GlaxoSmithKline Phase 1 2006-10-01 The first purpose of this study is to determine if taking SB-751689 along with Rosuvastatin (CRESTOR) or Atorvastatin (LIPITOR) will change how Rosuvastatin or Atorvastatin are absorbed and eliminated from the body. Rosuvastatin and Atorvastatin are prescription medications used to treat patients with high cholesterol. Patients who would take SB-751689 for osteoporosis might also take Rosuvastatin or Atorvastatin for high cholesterol. In an earlier study, SB-751689 was shown to lower the blood levels of Rosuvastatin when the two drugs were taken at the same time. Lower blood levels of Rosuvastatin could mean that it would not be as effective in lowering cholesterol. In this study SB-751689 will be taken alone, Rosuvastatin will be taken alone, SB-751689 and Rosuvastatin will be taken together, and SB-751689 will be taken 12 hours before Rosuvastatin is taken. This study will help determine if the two drugs should be taken 12 hour apart to prevent lower Rosuvastatin blood levels. Atorvastatin will be taken alone and at the same time as SB-751689 to determine if Atorvastatin blood levels are lower when taken at the same time as SB-751689. A second purpose of this study is to determine if taking another drug called Ketoconazole (Nizoral) along with SB-751689 will change how SB-751689 is absorbed and eliminated from the body. Ketoconazole is a prescription medication used to treat patients with fungal and yeast infections.
NCT00494663 A Phase 2b Study of DIO-902 or DIO-902 Placebo in Addition to Metformin and Atorvastatin or Atorvastatin Placebo for Type 2 Diabetes Terminated DiObex Phase 2 2007-07-01 DiObex Inc. is developing an experimental drug (DIO-902) that is made up of part of the ketoconazole molecule for the treatment of elevated blood glucose associated with type 2 diabetes mellitus. Ketoconazole (NizoralĀ®) is a drug available by prescription for the treatment of fungal infections however DIO-902 is an investigational drug. DIO-902 may lower blood glucose by lowering levels of a naturally occurring hormone called cortisol. Elevated cortisol may contribute to the development of type 2 diabetes. The purpose of this research study is to test the safety of DIO-902 when taken by mouth with metformin and the cholesterol-lowering drug atorvastatin to determine the type and severity of any side effects from this treatment. Other purposes of the study are to see how the treatment affects your blood glucose levels, cholesterol levels, blood pressure, and waist circumference.
NCT00622089 Open Label Safety & Pharmacodynamic Study 24Wk w/DIO-902 Combo w/Metformin & Atorvastatin in T2DM Patients Terminated DiObex Phase 2/Phase 3 2008-01-01 DiObex Inc. is developing an experimental drug (DIO-902) that is made up of part of the ketoconazole molecule for the treatment of elevated blood glucose associated with type 2 diabetes mellitus. Ketoconazole (NizoralĀ®) is a drug available by prescription for the treatment of fungal infections however DIO-902 is an investigational drug. DIO-902 may lower blood glucose by lowering levels of a naturally occurring hormone called cortisol. Elevated cortisol may contribute to the development of type 2 diabetes.
NCT01110330 An Efficacy Study of a New Formulation of Ketoconazole 2% Cream in Patients With Tinea Pedis, Commonly Known as Athlete's Foot Terminated Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Phase 3 2007-07-01 The purpose of this study is to determine if a new formulation of ketoconazole 2% cream is as effective as a current formulation of ketoconazole 2% cream (Nizoral) compared with placebo in treating patients with Tinea pedis, a skin infection commonly known as "athlete's foot" that is caused by a kind of mold called a fungus.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Nizoral A-d

Condition Name

Condition Name for Nizoral A-d
Intervention Trials
Tinea Pedis 4
Type 2 Diabetes 2
Sleep Restriction 2
Cancer of the Ovary 1
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Condition MeSH

Condition MeSH for Nizoral A-d
Intervention Trials
Tinea Pedis 4
Tinea 4
Diabetes Mellitus, Type 2 2
Carcinoma 2
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Clinical Trial Locations for Nizoral A-d

Trials by Country

Trials by Country for Nizoral A-d
Location Trials
United States 29
Australia 8
New Zealand 4
Brazil 2
United Kingdom 1
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Trials by US State

Trials by US State for Nizoral A-d
Location Trials
California 4
Texas 3
Oklahoma 3
Oregon 2
Nebraska 2
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Clinical Trial Progress for Nizoral A-d

Clinical Trial Phase

Clinical Trial Phase for Nizoral A-d
Clinical Trial Phase Trials
Phase 4 1
Phase 3 3
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Nizoral A-d
Clinical Trial Phase Trials
Completed 5
Recruiting 4
Not yet recruiting 3
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Clinical Trial Sponsors for Nizoral A-d

Sponsor Name

Sponsor Name for Nizoral A-d
Sponsor Trials
Biolab Sanus Farmaceutica 3
National Cancer Institute (NCI) 2
DiObex 2
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Sponsor Type

Sponsor Type for Nizoral A-d
Sponsor Trials
Industry 9
Other 7
NIH 2
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