A research study is conducted in people to evaluate a new investigational medical drug or device. The purpose of research studies is to find new and improved methods of treating different diseases in the future.
Research studies are typically conducted by a trained medical professional. An Institutional Review Board (IRB), or Ethics Committee (EC), review all research studies. This is a committee made up of doctors, ethicists, and members of the general public and administrators. This group helps to ensure that the rights of research participants are protected. Your regular doctor is responsible for your well-being and you may want to speak with your doctor before agreeing to participate in a study as there are possible risks associated with participation. Whenever you agree to enter a study, you are given the name and telephone number of a contact in your study physician's office who will answer your questions as well as a contact for the IRB or EC whom you can contact if you have questions or concerns.
In order to participate in this study, participants need to meet the following criteria:
There are additional criteria that are reviewed by the study team during your first appointment.
The study drug or placebo will be given once a day for six weeks. If you complete the 6-week treatment period, you may be eligible to participate in 52-week open-label study. An open-label study is when all participants receive the study drug.
You and the study participant will be asked to visit the clinic/study center once a week for a total of 6 weeks in order to be distributed the study drug and undergo a variety of health screenings.
Anyone agreeing to participate in a research study is required to sign an informed consent document. The informed consent document provides the details about the study and explains the potential risks and benefits. In addition, the informed consent document explains your rights and responsibilities. This document will tell you what study drug may be given, what kind of side effects might occur, and who to contact if you have questions or concerns.
Yes. Participants can withdraw from the study at any time. If you wish to withdraw from the study, you will be asked to notify the study team, give your reasons for stopping the study, and follow through with the study exit process.