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Generated: December 13, 2018

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CLINICAL TRIALS PROFILE FOR KETOCONAZOLE

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Clinical Trials for Ketoconazole

Trial ID Title Status Sponsor Phase Summary
NCT00000579 Acute Respiratory Distress Syndrome Clinical Network (ARDSNet) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 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 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 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 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 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 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 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 Sponsor Phase Summary

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Clinical Trial Conditions for Ketoconazole

Condition Name

Condition Name for Ketoconazole
Intervention Trials
Healthy 32
Prostate Cancer 22
Healthy Volunteers 8
Cancer 6
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Condition MeSH

Condition MeSH for Ketoconazole
Intervention Trials
Prostatic Neoplasms 32
Infection 6
HIV Infections 6
Tinea 6
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Clinical Trial Locations for Ketoconazole

Trials by Country

Trials by Country for Ketoconazole
Location Trials
United States 353
Australia 13
United Kingdom 10
Germany 8
Korea, Republic of 7
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Trials by US State

Trials by US State for Ketoconazole
Location Trials
Texas 31
California 25
New York 20
Illinois 15
Florida 13
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Clinical Trial Progress for Ketoconazole

Clinical Trial Phase

Clinical Trial Phase for Ketoconazole
Clinical Trial Phase Trials
Phase 4 16
Phase 3 20
Phase 2/Phase 3 8
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Clinical Trial Status

Clinical Trial Status for Ketoconazole
Clinical Trial Phase Trials
Completed 140
Terminated 18
Recruiting 15
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Clinical Trial Sponsors for Ketoconazole

Sponsor Name

Sponsor Name for Ketoconazole
Sponsor Trials
National Cancer Institute (NCI) 20
GlaxoSmithKline 19
Pfizer 8
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Sponsor Type

Sponsor Type for Ketoconazole
Sponsor Trials
Industry 133
Other 132
NIH 28
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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Boehringer Ingelheim
Daiichi Sankyo
QuintilesIMS
Fuji
UBS
Johnson and Johnson
Fish and Richardson
Express Scripts

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