The Envision GI study is a clinical research study for people who have been diagnosed with idiopathic gastroparesis. The main purpose of this study is to find out how well the study medication (CIN-102, deudomperidone) improves the symptoms associated with idiopathic gastroparesis.
You may be able to join the study if you meet the following requirements:
Age 18 or older
Confirmed diagnosis of idiopathic gastroparesis
Gastrointestinal symptoms within the last 6 months such as:
Other criteria apply. Talk to your doctor to learn more.
Contact a Study ClinicParticipation in the Envision GI study lasts up to 18 weeks. During this time, you can expect the following:
Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
The study medication, called CIN-102 or deudomperidone, is a new form of domperidone. Domperidone is used in some countries as a treatment for gastroparesis symptoms as well as issues with the stomach, such as nausea and vomiting. However, domperidone is not available in the US due to the potential for serious side effects. You will have the opportunity to review the potential benefits and risks of the study medication before deciding to participate.
Deudomperidone is made by slightly changing domperidone. It is expected to have similar benefits with fewer side effects. However, more research is needed.
Participants will be assigned at random (like the flip of a coin) to receive either the study medication (CIN-102) or placebo (no active ingredients).
Investigational means the study medication is not approved by regulatory authorities like the US Food and Drug Administration (FDA), and it can only be used in clinical research studies like the Envision GI study.
Idiopathic gastroparesis is a condition that prevents the stomach from emptying normally. It occurs without a known primary cause. Common symptoms include stomach discomfort, nausea, vomiting, upper abdominal pain, feeling full after consuming only a small amount of food, or feeling of persistent fullness after eating. These symptoms can be hard to manage and lead to other complications.
Although a medication (domperidone) to treat gastroparesis is used in some countries, it is not approved in the United States because it can have serious side effects. It can be used under a special agreement between a physician and the Food and Drug Administration. The study medication being investigated (deudomperidone) is designed to have similar benefits with fewer side effects. What we learn from the Envision GI study may help researchers learn more about a potential new idiopathic gastroparesis treatment option.
Other common terms for gastroparesis are:
Here are some common questions and answers about study participation.
Clinical research studies, or trials, help scientists and doctors explore whether a medical strategy, device, or medication is safe and effective for people. Before any medication can be approved and made available to the public, it must go through several phases of clinical research.
Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures you will receive.
Study participation usually involves visiting a clinic regularly, taking or receiving an investigational medicine, and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a study.
Participation in clinical research studies is your choice, and you may stop at any time.
Use the filters, map, and listing to find the study clinic closest to you.
Contact a study clinic to learn more.