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Ketoconazole

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61. Topical 5% Natamycin With Oral Ketoconazole in Filamentous Fungal Keratitis: A Randomized Controlled Trial. (Abstract)

Topical 5% Natamycin With Oral Ketoconazole in Filamentous Fungal Keratitis: A Randomized Controlled Trial. To assess the role of additive oral antifungal therapy in deep keratitis caused by filamentous fungi.A randomized, masked, double-blind clinical trial.All patients presenting with culture-positive fungal keratitis with a size measuring 2 to 60 mm2 and involving more than 50% of stromal depth were enrolled in 1 of the 2 treatment arms. Group A received 5% natamycin, whereas Group B (...) was given 200mg of oral ketoconazole twice a day in addition to 5% natamycin. Patients were followed up for 4 weeks. Liver function was assessed at baseline and at exit. Tests for significance included t test to compare the means of continuous variables, chi-square and Fisher's exact tests for comparing categorical variables and Kaplan-Meier procedure to estimate the survival rate.Of the 115 patients enrolled, 108 completed the study. Fifty-eight patients were in group A and 57 in group B

2015 Asia-Pacific journal of ophthalmology (Philadelphia, Pa.) Controlled trial quality: uncertain

62. Commentary on "Comparison of abiraterone acetate versus ketoconazole in patients with metastatic castration resistant prostate cancer refractory to docetaxel." Peer A, Gottfried M, Sinibaldi V, Carducci MA, Eisenberger MA, Sella A, Leibowitz-Amit R, Berge (Abstract)

Commentary on "Comparison of abiraterone acetate versus ketoconazole in patients with metastatic castration resistant prostate cancer refractory to docetaxel." Peer A, Gottfried M, Sinibaldi V, Carducci MA, Eisenberger MA, Sella A, Leibowitz-Amit R, Berge Abiraterone, a potent CYP 17 inhibitor, is standard treatment in docetaxel refractory, metastatic castrate resistant prostate cancer (mCRPC). However, in countries where abiraterone has not been approved yet, or for patients who cannot afford (...) it, ketoconazole is used as an alternative CYP 17 inhibitor. Although preclinical data suggests that ketoconazole is a less potent inhibitor of CYP 17, there are limited clinical data comparing both agents. We aimed to compare the clinical effectiveness of abiraterone versus ketoconazole in docetaxel refractory mCRPC.Records from mCRPC patients treated with ketoconazole (international multicenter database, n = 162) were reviewed retrospectively. Twenty-six patients treated post docetaxel were individually

2015 Urologic oncology

63. Terbinafin 1% Cream and Ketoconazole 2% Cream in the Treatment of Pityriasis Versicolor: A randomized comparative clinical trial. Full Text available with Trip Pro

Terbinafin 1% Cream and Ketoconazole 2% Cream in the Treatment of Pityriasis Versicolor: A randomized comparative clinical trial. To make a comparison between terbinafine 1% cream and ketoconazole 2% cream in the treatment of pityriasis versicolor.This randomized single blind study included 110 patients with clinical diagnosis of pityriasis versicolor and positive mycological test for Malassezia furfur. The patients were randomly assigned to two groups. Group 1 used terbinafine cream and group (...) 2 applied ketoconazole cream on the skin lesions for two weeks. Each group consisted of 55 patients. Clinical and mycological examinations were performed at baseline, at the end of the 2(nd), 4(th) and 8(th) week of starting the treatment regimens.At the end of the 2(nd) week we achieved cure rates of 72% and 64.3% for group 1 and group 2 respectively. At the end of the 4(th) week the respective cure rates for group 1 and group 2 were 81.2% and 69%, and at the end of the 8(th) week 70.8

2015 Pakistan journal of medical sciences Controlled trial quality: uncertain

64. Evaluation of Cytochrome P450 (CYP) 3A4-Based Interactions of Levomilnacipran with Ketoconazole, Carbamazepine or Alprazolam in Healthy Subjects. (Abstract)

Evaluation of Cytochrome P450 (CYP) 3A4-Based Interactions of Levomilnacipran with Ketoconazole, Carbamazepine or Alprazolam in Healthy Subjects. Levomilnacipran is a serotonin and norepinephrine reuptake inhibitor with balanced potency for the reuptake inhibition of norepinephrine and serotonin, approved in the USA for the treatment of major depressive disorder (MDD) in adults. We conducted studies in healthy human subjects to investigate pharmacokinetic interactions when levomilnacipran (...) extended-release (ER) is administered in combination with an inhibitor (ketoconazole), an inducer (carbamazepine), or a substrate (alprazolam) of cytochrome P450 (CYP) 3A4.Randomised, open-label studies were conducted in healthy volunteers (n = 34 ketoconazole, n = 34 carbamazepine, n = 30 alprazolam) and pharmacokinetic parameters were determined when levomilnacipran was administered alone or together with the relevant study drug.Co-administration of ketoconazole with levomilnacipran ER increased

2015 Clinical drug investigation Controlled trial quality: uncertain

65. Flea (Ctenocephalides felis) control efficacy of topical indoxacarb on dogs subsequently bathed with a chlorhexidine-ketoconazole shampoo. Full Text available with Trip Pro

Flea (Ctenocephalides felis) control efficacy of topical indoxacarb on dogs subsequently bathed with a chlorhexidine-ketoconazole shampoo. An evaluation of the effect of chlorhexidine/ketoconazole shampoo baths on the flea control efficacy of indoxacarb applied topically to dogs.We randomly allocated 18 healthy mixed-breed dogs to 3 groups: shampoo only; indoxacarb treated and medicated shampoo; and indoxacarb treated but not shampooed. Indoxacarb was administered on day 0 and dogs were

2015 Australian veterinary journal Controlled trial quality: uncertain

66. Pharmacokinetic interaction of intravenous fentanyl with ketoconazole. (Abstract)

Pharmacokinetic interaction of intravenous fentanyl with ketoconazole. Fentanyl is primarily metabolized by CYP3A, but has also been suggested to act as a weak inhibitor of CYP3A. We investigated the influence of CYP3A inhibition by ketoconazole on the pharmacokinetics of intravenously administered fentanyl and the effect of fentanyl on CYP3A activity. A prospective, open-label, randomized, monocentre, crossover study was conducted in 16 healthy volunteers. They received fentanyl alone (5 (...)  microgram per kilogram) or fentanyl plus ketoconazole (200 milligram orally B.I.D. over 2 days). Naloxone (2 × 0.2 milligram i.v.) was given simultaneously with fentanyl to mitigate any opioid effect. Midazolam was administered as a CYP3A probe drug. Fentanyl and its metabolites were quantified by LC/MS/MS in blood and urine samples obtained over 24 hour. Exposure of fentanyl (AUC0- ∞ ) was significantly increased to 133% and systemic clearance was reduced to 78% by ketoconazole, norfentanyl formation

2015 Journal of clinical pharmacology Controlled trial quality: uncertain

67. Pharmacokinetic interaction between the CYP3A4 inhibitor ketoconazole and the hormone drospirenone in combination with ethinylestradiol or estradiol. Full Text available with Trip Pro

Pharmacokinetic interaction between the CYP3A4 inhibitor ketoconazole and the hormone drospirenone in combination with ethinylestradiol or estradiol. The present study was conducted to investigate the influence of the strong CYP3A4 inhibitor ketoconazole (KTZ) on the pharmacokinetics of drospirenone (DRSP) administered in combination with ethinylestradiol (EE) or estradiol (E2).This was a randomized, multicentre, open label, one way crossover, fixed sequence study with two parallel treatment

2015 British journal of clinical pharmacology Controlled trial quality: uncertain

68. Effects of Ketoconazole on the Pharmacokinetics of Lenvatinib (E7080) in Healthy Participants Full Text available with Trip Pro

Effects of Ketoconazole on the Pharmacokinetics of Lenvatinib (E7080) in Healthy Participants Lenvatinib is an oral, multitargeted, tyrosine kinase inhibitor under clinical investigation in solid tumors. In vitro evidence indicates that lenvatinib metabolism may be modulated by ketoconazole, an inhibitor of CYP3A4 and p-glycoprotein.In this Phase I, single-center, randomized, open-label, two-period, crossover study, healthy adults (18-55 years; N = 18) were randomized to one of two sequences (...) (ketoconazole → placebo or vice versa). Ketoconazole (400 mg) or placebo was administered orally once daily for 18 days; a 5 mg dose of lenvatinib was orally administered on Day 5 of each treatment period. Blood samples were collected over 14 days and lenvatinib plasma concentrations measured by high-performance liquid chromatography/tandem mass spectrometry.Systemic exposure to lenvatinib increased slightly (15-19%) with coadministration of ketoconazole. Although the 90% confidence interval (CI) for area

2014 Clinical pharmacology in drug development Controlled trial quality: uncertain

69. Prevention of recurrent ischemic priapism with ketoconazole: evolution of a treatment protocol and patient outcomes. (Abstract)

Prevention of recurrent ischemic priapism with ketoconazole: evolution of a treatment protocol and patient outcomes. The management of recurrent ischemic priapism (RIP) is not clearly defined. Ketoconazole (KTZ) is used to treat RIP and produces a temporary hypogonadal state to suppress sleep-related erections (SREs), which often evolve into episodes of ischemic priapism in this population.We review our experience to prevent RIP using KTZ and present our outcomes using a decreased dose

2014 Journal Of Sexual Medicine

70. Efficacy of docetaxel-based chemotherapy following ketoconazole in metastatic castration-resistant prostate cancer: implications for prior therapy in clinical trials. (Abstract)

Efficacy of docetaxel-based chemotherapy following ketoconazole in metastatic castration-resistant prostate cancer: implications for prior therapy in clinical trials. Abiraterone acetate (AA) is a CYP17 inhibitor of androgen synthesis approved for use following docetaxel for metastatic castration-resistant prostate cancer (mCRPC); evaluation in the pre-docetaxel setting is ongoing. Given that the reported efficacy of AA is lower following docetaxel vs. pre-docetaxel, the potential exists (...) for cross resistance given docetaxel's partly androgen receptor targeting activity. The efficacy of docetaxel following ketoconazole (KC), a weaker and nonspecific inhibitor of CYP17, may provide some insights into this potential interaction. We retrospectively evaluated the efficacy of every 3-week docetaxel with prednisone (DP) in mCRPC previously exposed to KC compared to KC-naive patients.A randomized phase II trial of men with mCRPC treated with DP + AT-101 (bcl-2 inhibitor) vs. DP plus placebo

2014 Urologic oncology

71. Role of combined use of ketoconazole and tamsulosin in management of acute urinary retention due to benign prostatic obstruction (a randomized controlled trial). Full Text available with Trip Pro

Role of combined use of ketoconazole and tamsulosin in management of acute urinary retention due to benign prostatic obstruction (a randomized controlled trial). Ketoconazole has the ability to lower serum testosterone to castrate level within 48 h. As the prostate is an androgen-dependent organ, we investigated the effect of the use of tamsulosin in combination with ketoconazole in cases of acute urinary retention (AUR) due to benign prostatic obstruction (BPO).We recruited patients with AUR (...) secondary to BPO but those with hepatic or renal impairment were excluded. Following urethral catheterization, the participants were randomized into two equal groups. The first group received tamsulosin (0.4 mg o.d.) and ketoconazole (200 mg t.d.s.) while the second one had tamsulosin and placebo. The drugs were maintained for 7 days and then the patients were put on trial without catheter (TWOC). The successful cases were assessed with peak flow rate (PFR) and the post-void residual urine volume (PVRV

2014 Prostate cancer and prostatic diseases

72. Abiraterone acetate in metastatic castration-resistant prostate cancer: a retrospective review of the Princess Margaret experience of (I) low dose abiraterone and (II) prior ketoconazole. (Abstract)

Abiraterone acetate in metastatic castration-resistant prostate cancer: a retrospective review of the Princess Margaret experience of (I) low dose abiraterone and (II) prior ketoconazole. Abiraterone (AA) is a CYP17 inhibitor that prolongs survival in men with metastatic castration-resistant prostate cancer (mCRPC). Data suggest similar pharmacokinetics of 250-500 mg of AA with high-fat meals ('low-dose') and 1000 mg in the fasting state ('full-dose'). Ketoconazole (KT) is a less potent CYP17

2014 European Journal of Cancer

73. CHILD Syndrome: Effective Treatment of Ichthyosiform Naevus with Oral and Topical Ketoconazole. Full Text available with Trip Pro

CHILD Syndrome: Effective Treatment of Ichthyosiform Naevus with Oral and Topical Ketoconazole. 24696032 2015 09 21 2015 01 15 1651-2057 95 1 2015 Jan Acta dermato-venereologica Acta Derm. Venereol. CHILD syndrome: effective treatment of ichthyosiform naevus with oral and topical ketoconazole. 91-2 10.2340/00015555-1859 Liu Tao T Department of Dermatology, Tangdu Hospital, The Fourth Military Medical University, No.569 Xinsi Road, 710038 Xi'an, China. Qian Ge G Wang Xiao Xia XX Zhang Yan Guo YG (...) eng Case Reports Journal Article Research Support, Non-U.S. Gov't Sweden Acta Derm Venereol 0370310 0001-5555 0 Cytochrome P-450 CYP3A Inhibitors 0 Dermatologic Agents EC 1.1.- 3-Hydroxysteroid Dehydrogenases EC 1.1.1.170 Nsdhl protein, human R9400W927I Ketoconazole Congenital Hemidysplasia with Ichthyosiform Erythroderma and Limb Defects IM 3-Hydroxysteroid Dehydrogenases genetics Abnormalities, Multiple diagnosis drug therapy genetics Administration, Cutaneous Administration, Oral Adolescent

2014 Acta Dermato-Venereologica

74. Effect of ketoconazole on lobeglitazone pharmacokinetics in korean volunteers. (Abstract)

Effect of ketoconazole on lobeglitazone pharmacokinetics in korean volunteers. Lobeglitazone, a peroxisome proliferator-activated receptor-γ agonist, is metabolized primarily by the cytochrome P450 (CYP) 3A4 isoenzyme. Individuals concomitantly taking lobeglitazone and a CYP3A4 inhibitor may experience some adverse effects secondary to increased systemic exposure to lobeglitazone. To address such potential concern, we evaluated the effects of ketoconazole, a prototypic CYP3A4 inhibitor (...) , on the pharmacokinetic (PK) properties and associated adverse effects of lobeglitazone.A PK drug-drug interaction study was conducted in healthy individuals between 20 and 45 years old in a randomized, open-label, 2-way crossover design. Even though the PK study was performed on a single dose of lobeglitazone, multiple ketoconazole doses were given to ensure that the full extent of inhibition of CYP3A4 was maintained during the PK sampling. All study participants received a single oral dose of lobeglitazone 0.5 mg

2014 Clinical therapeutics Controlled trial quality: uncertain

75. Evaluation of the effect of food and ketoconazole on the pharmacokinetics of the smoothened inhibitor PF-04449913 in healthy volunteers. (Abstract)

Evaluation of the effect of food and ketoconazole on the pharmacokinetics of the smoothened inhibitor PF-04449913 in healthy volunteers. To evaluate the effect of a potent cytochrome P450 3A4 (CYP3A4) inhibitor, ketoconazole, and separately the effect of food on PF-04449913 pharmacokinetics in healthy volunteers.This was an open-label, two-sequence, three-period, three-treatment, single-dose, crossover study. Subjects were randomized to receive single doses of 200 mg PF-04449913 after (...) an overnight fast or after consuming a high-fat meal during Period 1 or 2, with a washout period of at least 8 days. In Period 3, all subjects received ketoconazole (400 mg/day) (days 1-7) and a co-administered single 200-mg PF-04449913 dose (day 4).Geometric mean ratio of PF-04449913 in the presence of ketoconazole versus PF-04449913 alone was 2.40 [90% confidence interval (CI) 2.15, 2.68] for area under the plasma concentration-time curve from time zero to infinity (AUC(0-inf)) and 1.40 (90% CI 1.24

2014 Cancer chemotherapy and pharmacology

76. Pharmacokinetic Interactions Between the Orexin Receptor Antagonist Almorexant and the CYP3A4 Inhibitors Ketoconazole and Diltiazem. (Abstract)

Pharmacokinetic Interactions Between the Orexin Receptor Antagonist Almorexant and the CYP3A4 Inhibitors Ketoconazole and Diltiazem. Almorexant, a tetrahydroisoquinoline orexin receptor antagonist and first representative of a new class of compounds for the treatment of insomnia, is a substrate of the cytochrome P450 3A4 isoenzyme (CYP3A4). Two randomized two-way crossover studies were performed in healthy subjects investigating the pharmacokinetic interaction between almorexant and the CYP3A4 (...) inhibitors ketoconazole and diltiazem. When administered as a single dose of 100 mg almorexant during steady state of ketoconazole (400 mg once daily for 14 days) or diltiazem treatment (300 mg once daily for 11 days), the exposure to almorexant was 10.5- and 3.5-fold, respectively, greater when compared with almorexant alone. Exposure to the phenol metabolites M3 and M8 increased in the presence of the CYP3A4 inhibitors, whereas that to M6 (dealkylated metabolite) decreased. Concomitant ketoconazole

2014 Journal of pharmaceutical sciences Controlled trial quality: uncertain

77. Multicenter, double-blind, parallel group study investigating the non-inferiority of efficacy and safety of a 2% miconazole nitrate shampoo in comparison with a 2% ketoconazole shampoo in the treatment of seborrhoeic dermatitis of the scalp. (Abstract)

Multicenter, double-blind, parallel group study investigating the non-inferiority of efficacy and safety of a 2% miconazole nitrate shampoo in comparison with a 2% ketoconazole shampoo in the treatment of seborrhoeic dermatitis of the scalp. This study investigated the non-inferiority of efficacy and tolerance of 2% miconazole nitrate shampoo in comparison with 2% ketoconazole shampoo in the treatment of scalp seborrheic dermatitis.A randomized, double-blind, comparative, parallel group (...) , multicenter study was done. A total of 274 patients (145 miconazole, 129 ketoconazole) were enrolled. Treatment was twice-weekly for 4 weeks. Safety and efficacy assessments were made at baseline and at weeks 2 and 4. Assessments included symptoms of erythema, itching, scaling ['Symptom Scale of Seborrhoeic Dermatitis' (SSSD)], disease severity and global change [Clinical Global Impressions (CGIs) and Patient Global Impressions (PGIs)].Miconazole shampoo is at least as effective and safe as ketoconazole

2014 Journal of Dermatological Treatment Controlled trial quality: uncertain

78. A randomized controlled trial of combination treatment with ketoconazole 2% cream and adapalene 0.1% gel in pityriasis versicolor. (Abstract)

A randomized controlled trial of combination treatment with ketoconazole 2% cream and adapalene 0.1% gel in pityriasis versicolor. Ketoconazole cream and adapalene gel are effective drugs against pityriasis versicolor. However, there are no reports on combination treatment with both compounds in pityriasis versicolor.To evaluate the efficacy and safety of combination therapy with adapalene 0.1% gel and ketoconazole 2% cream against pityriasis versicolor.Participants with pityriasis versicolor (...) were randomly assigned to two groups: the combination group was treated with adapalene 0.1% gel and ketoconazole 2% cream once daily, and the monotherapy group received ketoconazole 2% cream twice daily. The treatment lasted 2 weeks in both groups. Outcomes were assessed at baseline and 1, 2 and 4 weeks after the initiation of treatment.We noted clinically significant differences in total improvement rates between groups Weeks 1 and 2. A statistically significant difference was obtained Week 4

2014 Journal of Dermatological Treatment Controlled trial quality: uncertain

79. Effects of Ketoconazole on the Pharmacokinetic Properties of CG100649, A Novel NSAID: A Randomized, Open-Label Crossover Study in Healthy Korean Male Volunteers. (Abstract)

Effects of Ketoconazole on the Pharmacokinetic Properties of CG100649, A Novel NSAID: A Randomized, Open-Label Crossover Study in Healthy Korean Male Volunteers. CG100649, a novel selective cyclooxygenase-2 inhibitor that also inhibits carbonic anhydrase I/II, is expected to reduce the cardiovascular risk typical of other NSAIDs. Concurrent medications may influence the activities of the cytochrome P450 (CYP) 3A enzyme through which CG100649 is metabolized.This study was designed to evaluate (...) the influence of ketoconazole, a known strong inhibitor of CYP3A, on the pharmacokinetic properties of CG100649.This randomized, open-label, 2 × 2 crossover study was conducted in healthy Korean male volunteers. Each subject received the following 2 treatments in a randomly allocated sequence, separated by a washout period of 42 days: single oral dose of CG100649 6 mg, and concurrent dosing of CG100649 6 mg and ketoconazole 400 mg followed by ketoconazole 400 mg/d over 4 days. Blood samples

2014 Clinical therapeutics Controlled trial quality: uncertain

80. Fenretinide Lym-X-Sorb + Ketoconazole + Vincristine for Recurrent or Resistant Neuroblastoma

Fenretinide Lym-X-Sorb + Ketoconazole + Vincristine for Recurrent or Resistant Neuroblastoma Fenretinide Lym-X-Sorb + Ketoconazole + Vincristine for Recurrent or Resistant Neuroblastoma - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more (...) studies before adding more. Fenretinide Lym-X-Sorb + Ketoconazole + Vincristine for Recurrent or Resistant Neuroblastoma (SPOC2013-001) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. of clinical studies and talk to your health care provider before participating. Read our for details. ClinicalTrials.gov Identifier: NCT02163356 Recruitment Status

2014 Clinical Trials

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