This is a global, multicenter clinical trial to test the effectiveness and safety of an investigational drug called Relamorelin for the treatment of gastroparesis in people who also have diabetes mellitus.
An investigational drug is a drug that is not for sale in this country.
This is a 16 week long, placebo-controlled, double-blinded study. There is an equal chance that participants will be assigned Relamorelin OR placebo. Relamorelin is an injectable drug using a pre-filled pen injector that patients will self-administer twice a day.
Participants will attend 7 scheduled, weekday visits at the Heritage Medical Research Clinic at the Foothills Campus in Calgary. At these visits, blood and urine samples will be taken and participants will answer a variety of questionnaires. The second visit will include a 4-hour gastric emptying breath test at the research clinic as part of the screening process.
There is an option to participate in a sub-study that will measure gastric emptying time a second time as well as drug and hormone levels in the blood. In addition, all participants will complete a daily symptoms diary using an electronic diary that we provide.
Study medication and parking are provided free of charge and participants will receive honoraria.
You may be eligible to participate if you’re over the age of 18 living with Diabetes mellitus, type 1 or 2, for at least 5 years. Eligible participants will also have a history of gastroparesis symptoms (nausea, abdominal pain, post prandial fullness, early satiety, vomiting) for at least 3 months prior to screening.
For more information contact Study Co-ordinator Lynn Wilsack at 403 592-5045 or [email protected]