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Last Updated: May 28, 2024

CLINICAL TRIALS PROFILE FOR ITRACONAZOLE


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505(b)(2) Clinical Trials for Itraconazole

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 Dosage NCT02372357 ↗ A New Dosing Regimen for Posaconazole Prophylaxis in Children Based on Body Surface Area Completed Institutul Clinic Fundeni Phase 4 2012-02-01 A new prophylactic posaconazole dosing regimen of 120mg/m² tid is evaluated pharmacologically in children 13 years and younger, suffering from a hematologic malignancy.
New Dosage NCT02372357 ↗ A New Dosing Regimen for Posaconazole Prophylaxis in Children Based on Body Surface Area Completed Institutul Clinic Fundeni Bucharest Phase 4 2012-02-01 A new prophylactic posaconazole dosing regimen of 120mg/m² tid is evaluated pharmacologically in children 13 years and younger, suffering from a hematologic malignancy.
New Dosage NCT02372357 ↗ A New Dosing Regimen for Posaconazole Prophylaxis in Children Based on Body Surface Area Completed Universitaire Ziekenhuizen Leuven Phase 4 2012-02-01 A new prophylactic posaconazole dosing regimen of 120mg/m² tid is evaluated pharmacologically in children 13 years and younger, suffering from a hematologic malignancy.
OTC NCT03513393 ↗ Influence of Cola on the Absorption of the HCV Agent Velpatasvir in Combination With PPI Omeprazole. Completed 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 Itraconazole

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000639 ↗ A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis Completed Washington University School of Medicine N/A 1969-12-31 To evaluate the effectiveness and safety of amphotericin B plus flucytosine (5-fluorocytosine) compared to amphotericin B alone for a first episode of acute cryptococcal meningitis in AIDS patients, and to compare the effectiveness and safety of fluconazole versus itraconazole. At least 10 percent of patients with a low CD4 count and HIV infection will develop meningitis due to Cryptococcus neoformans. More effective treatments than the standard therapy need to be explored.
NCT00000639 ↗ A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 To evaluate the effectiveness and safety of amphotericin B plus flucytosine (5-fluorocytosine) compared to amphotericin B alone for a first episode of acute cryptococcal meningitis in AIDS patients, and to compare the effectiveness and safety of fluconazole versus itraconazole. At least 10 percent of patients with a low CD4 count and HIV infection will develop meningitis due to Cryptococcus neoformans. More effective treatments than the standard therapy need to be explored.
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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Itraconazole

Condition Name

Condition Name for Itraconazole
Intervention Trials
Healthy 68
Healthy Volunteers 24
Healthy Participants 18
Healthy Subjects 14
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Condition MeSH

Condition MeSH for Itraconazole
Intervention Trials
Mycoses 19
Aspergillosis 18
Infections 17
Infection 17
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Clinical Trial Locations for Itraconazole

Trials by Country

Trials by Country for Itraconazole
Location Trials
United States 342
China 34
Germany 31
United Kingdom 30
Canada 22
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Trials by US State

Trials by US State for Itraconazole
Location Trials
Texas 51
California 35
Kansas 22
Florida 20
Arizona 15
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Clinical Trial Progress for Itraconazole

Clinical Trial Phase

Clinical Trial Phase for Itraconazole
Clinical Trial Phase Trials
Phase 4 26
Phase 3 18
Phase 2/Phase 3 12
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Clinical Trial Status

Clinical Trial Status for Itraconazole
Clinical Trial Phase Trials
Completed 252
Recruiting 38
Not yet recruiting 35
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Clinical Trial Sponsors for Itraconazole

Sponsor Name

Sponsor Name for Itraconazole
Sponsor Trials
Pfizer 19
Boehringer Ingelheim 18
AstraZeneca 14
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Sponsor Type

Sponsor Type for Itraconazole
Sponsor Trials
Industry 296
Other 179
U.S. Fed 18
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