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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR MICONAZOLE 7

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Clinical Trials for Miconazole 7

Trial ID Title Status Sponsor Phase Summary
NCT00004575 Effects of Miconazole on Blood Flow Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 1 This study will investigate the effect of the drug miconazole on blood vessel dilation. Miconazole stops production of EDHF, a substance that causes arteries to dilate. EDHF is produced by the cells that line blood vessels. Normal volunteers between the ages of 21 to 60 may participate in this study. Candidates will be screened for eligibility with a medical history, physical examination, electrocardiogram and routine laboratory tests. Those enrolled will be injected with miconazole to study its effects on blood vessels. Study participants will take three aspirin tablets. After administration of a local anesthetic, small tubes will be inserted through a needle into the artery and vein of the forearm. These will be used to measure blood pressure and to draw blood samples during the study. Forearm blood flow will be measured using pressure cuffs placed on the wrist and upper arm, and a strain gauge (a rubber band device) placed around the forearm. When the cuffs are inflated, blood will flow into the arm, stretching the strain gauge, and the flow measurement will be recorded. Small doses of four drugs-bradykinin, sodium nitroprusside, miconazole, and LNMMA-will be given through the arterial catheter. Bradykinin stimulates the release of EDHF and can lower blood pressure. Sodium nitroprusside causes blood vessels to dilate and is used to treat high blood pressure and heart failure. Miconazole is commonly prescribed to treat various infections, including vaginal yeast infections, jock itch and athlete's foot. In much higher doses, it is used to treat fungal infections that have spread to the lungs, brain, kidneys, or bladder. LNMMA inhibits production of nitric oxide, another substance produced by the lining cells of blood vessels. Blood flow will be measured throughout the study, which will last approximately 3 hours.
NCT00128323 A Comparison of Gentian Violet (GV) Mouth Washes, Nystatin, and Ketoconazole Tabs in Treating Oropharyngeal Candidiasis Completed British Society for Antimicrobial Chemotherapy Phase 3 In resource constrained societies and where HIV is a problem, oral thrush causes significant morbidity. In adults, ketoconazole is used and sometimes oral nystatin. Both drugs are relatively expensive compared to GV solution and ketoconazole has significant side effects especially in association with some of the treatments for HIV related problems. In children, either GV solutions or nystatin are used, GV is a fraction of the cost of nystatin. GV at 1% solution discolours the mouth (blue) and in the older child and adult would mark them out as having HIV infections. A much more dilute solution of GV has proved equally effective in vitro and would not carry the same cosmetic problem. In this study of children, the investigators have compared the 3 solutions, 1% GV, 0.00165% GV and nystatin oral drops - all masked so that they look the same - to see if GV is more effective than nystatin, and to see if the weaker solution of GV is as effective as the stronger solution.
NCT00128323 A Comparison of Gentian Violet (GV) Mouth Washes, Nystatin, and Ketoconazole Tabs in Treating Oropharyngeal Candidiasis Completed University of Malawi College of Medicine Phase 3 In resource constrained societies and where HIV is a problem, oral thrush causes significant morbidity. In adults, ketoconazole is used and sometimes oral nystatin. Both drugs are relatively expensive compared to GV solution and ketoconazole has significant side effects especially in association with some of the treatments for HIV related problems. In children, either GV solutions or nystatin are used, GV is a fraction of the cost of nystatin. GV at 1% solution discolours the mouth (blue) and in the older child and adult would mark them out as having HIV infections. A much more dilute solution of GV has proved equally effective in vitro and would not carry the same cosmetic problem. In this study of children, the investigators have compared the 3 solutions, 1% GV, 0.00165% GV and nystatin oral drops - all masked so that they look the same - to see if GV is more effective than nystatin, and to see if the weaker solution of GV is as effective as the stronger solution.
NCT00390780 Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients Completed Onxeo Phase 3 The purpose of this study is to evaluate the clinical cure of miconazole Lauriad 50 mg (1x50mg) Bioadhesive buccal tablets compared with clotrimazole troches (5x10mg) after 14 days of treatment (at the test of cure visit, at Day 17-19).
NCT00498680 Safety and Clinical Effectiveness of 2 Lower Dose Combined PDE5i's vs. Single Maximal Dose PDE5i Unknown status Rambam Health Care Campus Phase 4 A prospective, randomized, 3-arm parallel trial on 45 males with ED that were never exposed to PDE5i therapy (naïve patients) will be enrolled.In each group, every patient will receive three treatment regimes (Viagra®50mg & Levitra®10mg, Viagra®100mg, Levitra®20mg), in different sequences of administration in such a manner that eventually each patient will receive all regimes in a double- blinded fasion.Safety will be evaluated at pre- screening by measuring hourly vital signs (blood pressure, heart rate)for 4 consecutive hours after taking half-dose combination. Any decrease in blood pressure of 20 mmhg below baseline will exclude the subject from the study. Effcacy will be evaluated by questionnaires (IIEF, Quality of erection questionnaire, grade of erection scale, Sear, QVS and Sexual Encounter Profiles for each sexual event). Non-parametric statistical analysis of the collected data Comparing the 3 groups will be performed.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Miconazole 7

Condition Name

Condition Name for Miconazole 7
Intervention Trials
Bacterial Vaginosis 3
Candidiasis, Oral 2
Healthy 2
Melasma 1
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Condition MeSH

Condition MeSH for Miconazole 7
Intervention Trials
Candidiasis 5
Vaginosis, Bacterial 3
Vaginal Diseases 3
Vaginitis 2
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Clinical Trial Locations for Miconazole 7

Trials by Country

Trials by Country for Miconazole 7
Location Trials
United States 24
China 7
Brazil 5
Canada 4
Kenya 2
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Trials by US State

Trials by US State for Miconazole 7
Location Trials
Florida 3
Alabama 3
Texas 2
Michigan 2
California 2
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Clinical Trial Progress for Miconazole 7

Clinical Trial Phase

Clinical Trial Phase for Miconazole 7
Clinical Trial Phase Trials
Phase 4 8
Phase 3 5
Phase 2 4
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Clinical Trial Status

Clinical Trial Status for Miconazole 7
Clinical Trial Phase Trials
Completed 17
Unknown status 4
Terminated 1
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Clinical Trial Sponsors for Miconazole 7

Sponsor Name

Sponsor Name for Miconazole 7
Sponsor Trials
University of Sao Paulo 2
National Institute of Allergy and Infectious Diseases (NIAID) 2
Embil Pharmaceutical Co. Ltd 2
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Sponsor Type

Sponsor Type for Miconazole 7
Sponsor Trials
Other 20
Industry 11
NIH 3
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US Department of Justice
Accenture
Daiichi Sankyo
McKinsey
Healthtrust
Johnson and Johnson
Fuji
Julphar
Chinese Patent Office

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