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Last Updated: December 23, 2024

CLINICAL TRIALS PROFILE FOR NIZORAL


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505(b)(2) Clinical Trials for NIZORAL

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

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002855 ↗ Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer Completed National Cancer Institute (NCI) Phase 3 1996-08-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy and androgen suppression may kill more tumor cells. It is not yet known which treatment regimen is more effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus hormone therapy versus androgen suppression alone as initial therapy in patients with prostate cancer that is metastatic or that cannot be removed surgically.
NCT00002855 ↗ Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer Completed M.D. Anderson Cancer Center Phase 3 1996-08-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy and androgen suppression may kill more tumor cells. It is not yet known which treatment regimen is more effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus hormone therapy versus androgen suppression alone as initial therapy in patients with prostate cancer that is metastatic or that cannot be removed surgically.
NCT00003084 ↗ Combination Chemotherapy With Ketoconazole in Treating Patients With Prostate Cancer Completed National Cancer Institute (NCI) Phase 2 1997-12-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy consisting of paclitaxel, etoposide, and estramustine as compared with ketoconazole plus doxorubicin, vinblastine, and estramustine in treating patients with prostate cancer.
NCT00003084 ↗ Combination Chemotherapy With Ketoconazole in Treating Patients With Prostate Cancer Completed M.D. Anderson Cancer Center Phase 2 1997-12-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy consisting of paclitaxel, etoposide, and estramustine as compared with ketoconazole plus doxorubicin, vinblastine, and estramustine in treating patients with prostate cancer.
NCT00006371 ↗ A Phase II Trial of Early Medical Adrenalectomy for "D0.5" Prostate Cancer Terminated Janssen Pharmaceuticals Phase 2 2000-05-01 RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as aminoglutethimide or ketoconazole may stop the adrenal glands from producing hormones. Combining hydrocortisone with either aminoglutethimide or ketoconazole may be an effective treatment for prostate cancer. PURPOSE: Phase II trial to study the effectiveness of combining hydrocortisone with either aminoglutethimide or ketoconazole in treating patients who have localized stage IV prostate cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for NIZORAL

Condition Name

Condition Name for NIZORAL
Intervention Trials
Prostate Cancer 8
Tinea Pedis 5
Type 2 Diabetes 2
Healthy Subjects 2
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Condition MeSH

Condition MeSH for NIZORAL
Intervention Trials
Prostatic Neoplasms 11
Tinea Pedis 5
Tinea 5
Carcinoma 2
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Clinical Trial Locations for NIZORAL

Trials by Country

Trials by Country for NIZORAL
Location Trials
United States 68
Australia 8
New Zealand 4
Brazil 2
United Kingdom 1
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Trials by US State

Trials by US State for NIZORAL
Location Trials
Texas 9
California 7
Nebraska 4
Florida 4
New York 4
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Clinical Trial Progress for NIZORAL

Clinical Trial Phase

Clinical Trial Phase for NIZORAL
Clinical Trial Phase Trials
Phase 4 1
Phase 3 6
Phase 2/Phase 3 1
[disabled in preview] 13
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Clinical Trial Status

Clinical Trial Status for NIZORAL
Clinical Trial Phase Trials
Completed 15
Terminated 10
Recruiting 5
[disabled in preview] 3
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Clinical Trial Sponsors for NIZORAL

Sponsor Name

Sponsor Name for NIZORAL
Sponsor Trials
National Cancer Institute (NCI) 7
Biolab Sanus Farmaceutica 3
M.D. Anderson Cancer Center 3
[disabled in preview] 6
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Sponsor Type

Sponsor Type for NIZORAL
Sponsor Trials
Other 35
Industry 17
NIH 7
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