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Last Updated: August 11, 2020

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CLINICAL TRIALS PROFILE FOR KETOCONAZOLE

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505(b)(2) Clinical Trials for Ketoconazole

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.
OTC NCT03513393 Influence of Cola on the Absorption of the HCV Agent Velpatasvir in Combination With PPI Omeprazole. Not yet recruiting Radboud University Phase 1 2018-08-01 Epclusa® is a pan-genotypic, once-daily tablet for the treatment of chronic hepatitis C virus (HCV) infection containing the NS5B- polymerase inhibitor sofosbuvir (SOF, nucleotide analogue) 400 mg and the NS5A inhibitor velpatasvir (VEL) 100 mg. Velpatasvir has pH dependent absorption. At higher pH the solubility of velpatasvir decreases. It has been shown that in subjects treated with proton pump inhibitors (PPIs) such as omeprazole, the absorption of velpatasvir is reduced by 26-56%, depending on the dose of omeprazole, concomitant food intake, and timing/sequence of velpatasvir vs. omeprazole intake. As a result, concomitant intake of PPIs with velpatasvir is not recommended. For a number of reasons, the prohibition of PPI use with velpatasvir is a clinically relevant problem. First, PPI use is highly frequent in the HCV-infected subject population with prevalences reported up to 40%. Second, PPIs are available as over-the-counter medications and thus can be used by subjects without informing their physician. Third, although HCV therapy is generally well tolerated, gastro-intestinal symptoms such as abdominal pain and nausea are frequently reported, which my lead to PPI use. One solution of this problem could be the use of other acid-reducing agents such as H2-receptor antagonists or antacids. In general, they have a less pronounced effect on intragastric pH, and are considered less effective than PPIs by many patients and physicians. A second solution would be the choice of another HCV agent or combination that is not dependent on low gastric pH for its absorption such as daclatasvir. Daclatasvir, however, is not a pan-genotypic HCV agent and may be less effective against GT 2 and 3 infections than velpatasvir. Second, not all subjects have access to daclatasvir, depending on health insurance company or region where they live. A third solution, and the focus of this COPA study, is to add a glass of the acidic beverage cola at the time of velpatasvir administration in subjects concurrently treated with PPIs. This intervention has been shown to be effective for a number of drugs from other therapeutic classes who all have in common a reduced solubility (and thus reduced absorption) at higher intragastric pH, namely erlotinib, itraconazole, ketoconazole. The advantages of this approach are: (1) only a temporary decrease in gastric pH at the time of cola intake; the rest of the day the PPI will have its therapeutic effect (2) cola is available worldwide (3) the administration of cola can be done irrespective to the timing of PPI use.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Ketoconazole

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000579 Acute Respiratory Distress Syndrome Clinical Network (ARDSNet) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1994-09-01 The purposes of this study are to assess rapidly innovative treatment methods in patients with adult respiratory distress syndrome (ARDS) as well as those at risk of developing ARDS and to create a network of interactive Critical Care Treatment Groups (CCTGs) to establish and maintain the required infrastructure to perform multiple therapeutic trials that may involve investigational drugs, approved agents not currently used for treatment of ARDS, or treatments currently used but whose efficacy has not been well documented.
NCT00000975 A Study of Itraconazole in the Treatment and Prevention of Histoplasmosis, a Fungal Infection, in Patients With AIDS Completed Janssen Pharmaceuticals Phase 2 1969-12-31 To evaluate the feasibility of itraconazole as (1) primary therapy in histoplasmosis and (2) maintenance therapy after completion of primary therapy. To evaluate the effect of therapy of CNS histoplasmosis. To determine if resistance to drug occurs in patients who fail therapy. Histoplasmosis is a serious opportunistic infection in patients with AIDS. Although the clinical response to amphotericin B treatment in the AIDS patients is generally good, administration difficulties and toxicity detract from its usefulness. Oral treatment with ketoconazole overcomes these limitations of amphotericin B, but does not appear to be effective for primary treatment in patients with AIDS. Itraconazole is a triazole compound in which preclinical studies have demonstrated activity against Histoplasmosis capsulatum. Preclinical studies have also shown that itraconazole appears effective in the treatment of histoplasmosis. The frequency of adverse reactions to itraconazole has been low in several studies. Central nervous system (CNS) involvement occurs in up to 20 percent of patients with histoplasmosis, and appears to have a poor response to amphotericin B treatment. Itraconazole has been used successfully in a small number of patients with cryptococcal meningitis, supporting a study of its use in CNS histoplasmosis.
NCT00000975 A Study of Itraconazole in the Treatment and Prevention of Histoplasmosis, a Fungal Infection, in Patients With AIDS Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 To evaluate the feasibility of itraconazole as (1) primary therapy in histoplasmosis and (2) maintenance therapy after completion of primary therapy. To evaluate the effect of therapy of CNS histoplasmosis. To determine if resistance to drug occurs in patients who fail therapy. Histoplasmosis is a serious opportunistic infection in patients with AIDS. Although the clinical response to amphotericin B treatment in the AIDS patients is generally good, administration difficulties and toxicity detract from its usefulness. Oral treatment with ketoconazole overcomes these limitations of amphotericin B, but does not appear to be effective for primary treatment in patients with AIDS. Itraconazole is a triazole compound in which preclinical studies have demonstrated activity against Histoplasmosis capsulatum. Preclinical studies have also shown that itraconazole appears effective in the treatment of histoplasmosis. The frequency of adverse reactions to itraconazole has been low in several studies. Central nervous system (CNS) involvement occurs in up to 20 percent of patients with histoplasmosis, and appears to have a poor response to amphotericin B treatment. Itraconazole has been used successfully in a small number of patients with cryptococcal meningitis, supporting a study of its use in CNS histoplasmosis.
NCT00000992 A Study of Itraconazole in Preventing the Return of Histoplasmosis, a Fungal Infection, in Patients With AIDS Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1969-12-31 To test the effectiveness of itraconazole in preventing the recurrence of disseminated histoplasmosis in AIDS patients. Histoplasmosis is a serious opportunistic infection in patients with AIDS. Amphotericin B has been used to treat the infection. Although the response to this treatment is generally good, up to 90 percent of AIDS patients who have taken amphotericin B to treat their histoplasmosis infection will have a relapse (that is, they will get the disease again) within 12 months following treatment. Ketoconazole has been used to prevent relapse, but available information suggests that up to 50 percent of AIDS patients relapse even with ketoconazole treatment. A more effective therapy to prevent recurrence is needed. Itraconazole has been used successfully to treat disseminated histoplasmosis in non-AIDS patients and it is hoped that it may be more effective in preventing histoplasmosis relapse.
NCT00002304 A Comparison of Fluconazole and Ketoconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems Completed Pfizer N/A 1969-12-31 To compare the safety, tolerance, and effectiveness of fluconazole and ketoconazole in the treatment of candidal esophagitis in immunocompromised patients.
NCT00002760 Antiandrogen Withdrawal in Treating Patients With Hormone-Refractory Prostate Cancer Completed National Cancer Institute (NCI) Phase 3 1996-08-01 RATIONALE: Antiandrogen withdrawal may be an effective treatment for prostate cancer. PURPOSE: Randomized phase III trial to study the effectiveness of ketoconazole and hydrocortisone for antiandrogen withdrawal in treating men with prostate cancer that is refractory to hormone therapy.
NCT00002760 Antiandrogen Withdrawal in Treating Patients With Hormone-Refractory Prostate Cancer Completed Alliance for Clinical Trials in Oncology Phase 3 1996-08-01 RATIONALE: Antiandrogen withdrawal may be an effective treatment for prostate cancer. PURPOSE: Randomized phase III trial to study the effectiveness of ketoconazole and hydrocortisone for antiandrogen withdrawal in treating men with prostate cancer that is refractory to hormone therapy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ketoconazole

Condition Name

Condition Name for Ketoconazole
Intervention Trials
Healthy 33
Prostate Cancer 22
Healthy Volunteers 8
Cancer 6
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Condition MeSH

Condition MeSH for Ketoconazole
Intervention Trials
Prostatic Neoplasms 34
Tinea 8
Tinea Pedis 6
Dermatitis 6
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Clinical Trial Locations for Ketoconazole

Trials by Country

Trials by Country for Ketoconazole
Location Trials
United States 360
Australia 13
China 12
United Kingdom 10
Korea, Republic of 9
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Trials by US State

Trials by US State for Ketoconazole
Location Trials
Texas 31
California 26
New York 21
Illinois 15
Pennsylvania 15
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Clinical Trial Progress for Ketoconazole

Clinical Trial Phase

Clinical Trial Phase for Ketoconazole
Clinical Trial Phase Trials
Phase 4 20
Phase 3 25
Phase 2/Phase 3 9
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Clinical Trial Status

Clinical Trial Status for Ketoconazole
Clinical Trial Phase Trials
Completed 144
Not yet recruiting 21
Recruiting 18
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Clinical Trial Sponsors for Ketoconazole

Sponsor Name

Sponsor Name for Ketoconazole
Sponsor Trials
National Cancer Institute (NCI) 21
GlaxoSmithKline 19
AstraZeneca 8
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Sponsor Type

Sponsor Type for Ketoconazole
Sponsor Trials
Other 145
Industry 143
NIH 29
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