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Generated: December 17, 2018

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CLINICAL TRIALS PROFILE FOR FLORINEF

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Clinical Trials for Florinef

Trial ID Title Status Sponsor Phase Summary
NCT00011778 PS-341 and Radiation to Treat Advanced Cancer of the Head and Neck Completed National Cancer Institute (NCI) Phase 1 This study will test the safety and effects of the experimental drug PS-341 plus radiation therapy in patients with head and neck cancer. PS-341 can slow or halt the growth of cancer cells grown in culture or in mice. In addition, the drug appears to enhance the effectiveness of radiation treatment. Patients 18 years of age and older with head and neck cancer that cannot be treated adequately with surgery and cannot be cured with standard radiation and chemotherapy may be eligible for this study. Patients whose cancer has spread to the brain may not participate. Before treatment begins participants are evaluated with CT or MRI scans of the head, neck and chest area to determine the extent of the cancer; an electrocardiogram and blood tests; and a neurocardiovascular evaluation that includes measuring blood pressure in different body positions and involves injections of phenylephrine and nitroglycerine. Some patients may undergo a procedure in which a tube is inserted into the larynx (voice box), bronchi (breathing tubes) and esophagus (food tube) and tissue samples removed. This procedure is done under general anesthesia in the operating room. Patients receive radiation treatments Monday through Friday and injections of PS-341 twice a week during the radiation therapy. After 3 weeks of treatment, PS-341 injections are stopped for 2 weeks. Some patients continue to receive radiation treatments during the 2-week break, and others do not, depending upon when they enter the trial. The total duration of radiation treatment varies from 6 to 8 weeks, depending on whether the patient received radiation in the region of the head and neck cancer before entering the study. Patients have a blood sample drawn before and after each new PS-341 injection to measure the drug action in the blood and to see how strong and how long the effects on the blood last. They are seen in the clinic at least once a week for a history and physical examination. A blood sample is collected at each visit to look for toxic effects of PS-341. Near the end of treatment, the neurocardiovascular evaluation is repeated, and if the results are abnormal, it is repeated again 3 months after treatment is completed. X-rays or MRI scans are done 12 weeks after radiation therapy has ended and then every few months after that to determine the extent of disease. Patients whose tumor is accessible are asked to undergo a biopsy (removal of a small piece of tumor tissue) on the first and second day after receiving the first PS-341 dose to examine the effect of the drug on the tumor. The PS-341 dose is increased in successive groups of at least 3 patients until the highest dose that can be given safely with radiation is reached. Patients who develop severe side effects from the drug temporarily stop taking it to allow the side effects to improve. If needed, the dose may be decreased. Radiation therapy may also be stopped temporarily in patients who develop severe effects on the mouth, throat or skin. Side effects may be treated with increased fluid (by mouth, stomach tube, or vein), anti-nausea or anti-diarrhea medications, pain medications and medications to boost red or white cell counts or platelets. The drug Florinef may be given to help regulate body fluids and blood pressure.
NCT00117585 Orthostatic Hypotension in Rehabilitation Patients Completed VA Office of Research and Development N/A The purpose of this study is to determine the prevalence and clinical course of orthostatic hypotension (OH) on a rehabilitation and nursing home unit during their inpatient stay and to initiate a standardized, interdisciplinary treatment plan for patients with OH and determine the effect of treatment on the clinical course of OH during their inpatient stay.
NCT00529841 Research Study for Children With Salt Wasting Congenital Adrenal Hyperplasia Completed Baylor College of Medicine N/A The purpose of this study is to develop a more physiological approach to the management of children and adolescents with salt wasting Congenital Adrenal Hyperplasia. We will administer the glucocorticosteroid via insulin infusion pump to see whether this treatment will improve the serum hormone concentrations.
NCT01648998 Fludrocortisone and Information Processing in Healthy Volunteers Completed Leiden University Medical Center Phase 1 Stimulating the mineralocorticoid receptor (MR) may restore a disturbed balance as seen in depression. In this double-blind, randomized, placebo-controlled trial the investigators will test the effects of a single dose (500mg) fludrocortisone, an MR-agonist, on the information processing in healthy female volunteers (N = 2x20). The investigators want to investigate whether the acute administration of fludrocortisone (FC) in healthy females enhances the appraisal of emotional information related to depression, hypothesizing that: - FC relative to placebo selectively improves the recognition of happy and fearful faces: resulting in more correct responses and faster RTs. - FC induces a bias towards more positive self-description and an improved memory for positive information. Female participants were selected because the haplotype MRI180V is related to depression vulnerability in women, not in men. If the effects of fludrocortisone are comparable to the effects of antidepressants on the same tests and the same population, it might be a first indication that fludrocortisone may function as an antidepressant.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Florinef

Condition Name

Condition Name for Florinef
Intervention Trials
Depression 1
Autonomic Disturbances in Parkinson`s Disease 1
Adrenal Hyperplasia, Congenital 1
Squamous Cell Carcinoma 1
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Condition MeSH

Condition MeSH for Florinef
Intervention Trials
Adrenal Hyperplasia, Congenital 1
Hypotension, Orthostatic 1
Parkinson Disease 1
Hypotension 1
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Clinical Trial Locations for Florinef

Trials by Country

Trials by Country for Florinef
Location Trials
United States 4
Switzerland 1
Netherlands 1
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Trials by US State

Trials by US State for Florinef
Location Trials
Massachusetts 1
Texas 1
Oregon 1
Maryland 1
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Clinical Trial Progress for Florinef

Clinical Trial Phase

Clinical Trial Phase for Florinef
Clinical Trial Phase Trials
Phase 2 1
Phase 1 3
N/A 2
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Clinical Trial Status

Clinical Trial Status for Florinef
Clinical Trial Phase Trials
Completed 4
Active, not recruiting 1
Recruiting 1
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Clinical Trial Sponsors for Florinef

Sponsor Name

Sponsor Name for Florinef
Sponsor Trials
University of Zurich 1
Leiden University Medical Center 1
Baylor College of Medicine 1
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Sponsor Type

Sponsor Type for Florinef
Sponsor Trials
Other 4
U.S. Fed 1
NIH 1
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Serving hundreds of leading biopharmaceutical companies globally:

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