A clinical trial is an organized study conducted in order to answer specific questions about a new treatment or a new way of using a known treatment. Each study tries to increase medical knowledge and to find new and better ways to help patients. Besides studying new drugs, clinical trials study new combinations of drugs already used, new ways of giving treatment, and how changes in lifestyle can help patients. Other clinical trials compare the best known standard therapy with a newer therapy to see if one produces more cures and causes fewer side effects than the other.
Most clinical trials are carried out in steps called phases. Each phase is designed to find different information. Patients may be eligible for studies in different phases, depending on their general condition, the type and stage of their disorder, and what therapy, if any, they have already had. Patients are seen regularly to determine the effect of the treatment, and treatment is always stopped if side effects become too severe. With information aboutongoing and upcoming clinical trials around the world and all the latest news on medical advances, this section promises to be yet another important source of information for pituitary patients.
For current clinical trials, go to www.clinicaltrials.gov
Do you have high prolactin levels? Would you like to advance science and help others like you?
The purpose of this study is to evaluate the use of the non-ergoline dopamine agonist ropinirole for the treatment of hyperprolactinemia in patients with idiopathic hyperprolactinemia and prolactinomas.
Treatment of prolactin secreting pituitary tumors with traditional ergot dopamine agonist drugs can be limited by medication side effects, pharmacologic resistance, and by concerns regarding the potential risk of cardiac valve disease. The overall goal of this project is therefore to evaluate, for the first time, the efficacy and tolerability of the selective D2/D3 receptor non-ergot dopamine agonist ropinirole for the treatment of prolactinomas. This proposal will establish the pharmacologic profile of this medication when used to treat hyperprolactinemia in patients with prolactinomas and will determine the impact of long-term ropinirole administration on critical clinical parameters including serum prolactin levels, gonadal function, and tumor regression, in order to establish ropinirole's utility as a new, clinically efficacious, safer and more tolerable therapeutic option for the treatment of prolactinomas that may prove particularly useful in patients with underlying cardiac valve disease and in those with resistance or intolerance to ergot dopamine agonists.
Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing's Disease or Acromegaly
The purpose of this research study is to determine the best treatment for hyperglycemia that may occur from receiving the study drug, pasierotide, which is being provided for the treatment of Cushing’s disease or acromegaly. In Cushing’s disease, the tumor of the pituitary gland causes the adrenal glands to secrete an excess of cortisol, leading to many of the disease’s harmful effects. Pasireotide reduces the amount of cortisol produced by the adrenal glands. Pasireotide is approved in Europe and in the USA as a subcutaneous formulation (injected beneath the skin) under the trade name Signifor® s.c. for the treatment of people with Cushing’s disease. Acromegaly is characterized by the overproduction of growth hormone (GH) by the pituitary gland. In over 95% of patients with acromegaly, the disease is caused by a GH-secreting pituitary adenoma (benign or non-cancerous tumor in the pituitary gland). Pasireotide has also been developed as a long-acting release formulation (LAR) for the treatment of acromegaly, which acts by reducing the level of growth hormone in the blood. Pasireotide LAR has been approved by the Food and Drug Administration as an intramuscular injection (injected into the muscle) under the trade name Signifor® LAR for the treatment of people with acromegaly. Hyperglycemia was a frequently observed adverse drug reaction during the pasireotide clinical studies. This study is designed to evaluate the safety and effectiveness of incretin based anti-diabetic therapy (sitagliptin followed by liraglutide) compared to insulin following treatment with pasireotide.
For more information contact:
Tamika Wong, MPH
Clinical Research Manager
E: [email protected]
The purpose of this research study is to confirm the effectiveness and safety of osilodrostat in treating patients with Cushing’s disease. Osilodrostat is an investigational drug that has not yet been approved by the Food and Drug Administration (FDA). The safety of the osilodrostat is being tested at different dose levels. Twelve patients with Cushing’s disease have been treated with this study drug for 10 weeks and nineteen patients have been treated for 22 weeks. Results showed that osilodrostat was effective in reducing the cortisol level in all of them. In addition, another large study is ongoing, in which patients will receive osilodrostat for up to 96 weeks.
Osilodrostat is a potent, oral inhibitor of 11β-hydroxylase (CYP11B1), the enzyme that catalyzes the last step in the biosynthesis of cortisol. The current development activity of osilodrostat is focused on the treatment of patients with Cushing’s disease (hypercortisolism due to a pituitary corticotroph adenoma), because it is the most common cause of Cushing’s syndrome and it is a relatively homogeneous patient group. This drug also inhibits aldosterone synthase (CYP11B2), and therefore is a dual inhibitor of both cortisol and aldosterone synthesis. This study is sponsored by the pharmaceutical company named Novartis. Around 69 patients will join this study in approximately 35 centers located in different countries (around 12) across the world.
For more information contact:
Tamika Wong, MPH
Clinical Research Manager
E: [email protected]
Database Gives Public Easy Access to Information About Research Studies
(BETHESDA, MD) - The National Institutes of Health today announced the launch of the first phase of a consumer-friendly database, ClinicalTrials.gov, with information on more than 4,000 federal and private medical studies involving patients and others at more than 47,000 locations nationwide. The new database may be reached at www.clinicaltrials.gov.
Clinical trials are medical research studies that seek to evaluate the safety and effectiveness of new drugs, medical procedures, or other means of treating, diagnosing, or preventing diseases. This type of research helps investigators learn how different people respond to medications or other therapeutic approaches, and such investigations may lead to new or improved treatments. Trials are conducted when there is no proven treatment for a specific disease, or to test which treatment works best for a particular disease or condition.
ClinicalTrials.gov provides patients, families and members of the public easy access to information about the location of clinical trials, their design and purpose, criteria for participation, and, in many cases, further information about the disease and treatment under study. There are also contact points for individuals responsible for recruiting participants for each study.
Acting NIH Director Ruth L. Kirschstein, M.D., said, "Through this new database, NIH offers up-to-date information on promising patient-oriented research on hundreds of diseases and conditions. Most of the 4,000 clinical trials now in the database are funded by NIH Institutes and Centers, and result from a long, fruitful partnership between NIH and the American people who support and participate in our work."
"If we are to continue making the giant strides in diagnosis, treatment, and cure of illness that marked the last century, we must have active participation in clinical trials by well-informed volunteers," said Donald A.B. Lindberg, M.D., Director of NIH's National Library of Medicine, which developed and administers the new database. "ClinicalTrials.gov is a resource that will benefit trial participants, researchers, health care professionals and, over time, the general public."
Dr. Lindberg noted that ClinicalTrials.gov may also be reached through the National Library of Medicine's Web site at http://www.nlm.nih.gov and through its consumer health information service, MEDLINEplus at http://medlineplus.gov. MEDLINEplus has extensive links to information about 350 diseases and health conditions, much of it from the NIH Institutes and Centers.
ClinicalTrials.gov grew out of 1997 legislation that required the Department of Health and Human Services, through the NIH, to broaden the public's access to information about clinical trials on a wide range of diseases by establishing a registry for both federally and privately funded trials "on drugs for serious or life-threatening diseases and conditions." (Section 113, "Information Program on Clinical Trials for Serious or Life-Threatening Diseases," Food and Drug Administration Modernization Act of 1997, Public Law 105-115.)
"The project is proceeding in several major phases," noted Alexa T. McCray, Ph.D., who directs the ClinicalTrials.gov project at the National Library of Medicine. "In the first phase we were interested in collecting information primarily about studies that are being funded by NIH, or that are being conducted right here on the NIH campus. With the release of ClinicalTrials.gov, the first phase is well under way. In the next phase we will include non-NIH sponsored trials from other Federal agencies and private industry."
ClinicalTrials.gov is a completely confidential Web site. No registration or personal identification of any kind is required. People who search the site will not be contacted by the sponsors of clinical trials or by anyone else.
Note: Background information about clinical trials and specific information about the new database is available. The information, in the form of a "Q&A" document, may be requested by email from [email protected] or by phone from 301-496-6308. It is also linked to this press release on the Web at http://www.nlm.nih.gov/nn.html.
NLM also has a listing of current and past clinical trial participants who are available to discuss their experience in locating and participating in a medical study, and statements of support from consumer health organizations such as the American Cancer Society and the American Liver Foundation. These are available by calling 301-496-6308.
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