A clinical research trial is used in medicine to evaluate new drugs, medical devices, biologics, or other interventions on patients in strictly scientifically controlled settings, and are required for regulatory authority approval of new therapies. Trials may be designed to assess the safety and efficacy of an experimental therapy, to assess whether the new intervention is better than standard therapy, or to compare the efficacy of two standard or marketed interventions. The trial objectives and design are usually documented in a clinical trial protocol. A placebo, an inert compound, identical in appearance to a medication being studied, is sometimes used in clinical research trials.

Good clinical practice guidelines are standards provided by International Conference on Harmonisation (ICH) – an international body that regulates clinical trials involving human subjects. These guidelines include protection of human rights as a subject in clinical trial, how clinical trials should be conducted, define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and Clinical research associates.

An institutional review board/independent ethics committee (IRB/IEC) (also known as ethical review board) is a group that has been formally designated to review and monitor biomedical and behavioral research involving human subjects. In the United States, IRBs are mandated by the Research Act of 1974, which defines IRBs and requires them for all research that receives funding, directly or indirectly, from the Department of Health and Human Services (HHS). In accordance with Food and Drug Administration (FDA) and HHS regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. An IRB performs critical oversight functions for research conducted on human subjects that are scientific, ethical, and regulatory.

The following clinical research trials are ongoing at Dr. Levenson’s and Dr. Kao’s office:

Gastroesophageal Reflux Disease (GERD) is a disease that causes acid reflux producing symptoms such as chest pain, heartburn (a burning sensation in the chest), nausea, and vomiting. One of the most common treatments for GERD are proton pump inhibitors (PPIs).

This is an 8 week clinical trial to determine if an investigational drug is effective in the treatment of GERD in people who continue to experience GERD symptoms while receiving PPIs.

PPIs are prescription and over-the-counter medications, such as esomeprazole (Nexium) or omeprazole (Prilosec) that are commonly used to treat this condition. You will continue to take your PPI without any changes in the dose throughout the duration of this study. For more information click here.

Ulcerative colitis (UC) is an inflammatory bowel disease that causes long-lasting inflammation and ulcers (sores) in your digestive tract. Ulcerative colitis affects the innermost lining of your large intestine (colon) and rectum. Symptoms usually develop over time, rather than suddenly.

Ulcerative colitis inflammation may cause abdominal pain, diarrhea, fever, fatigue, weight loss, and other symptoms that vary from person to person and from mild to severe.

This is an 8 week trial evaluating the effectiveness of an oral probiotic capsule in treating patients with ulcerative colitis on mesalamine treatment who have ongoing symptoms of bleeding and diarrhea. For more information click here.

If you are interested in any of the above mentioned studies or for more information, please call (650) 596-8800, extension 19.

Please continue to check this website for additional study details as they begin! Thank you.