Idiopathic Gastroparesis - Brooklyn NY

Summary:

What is idiopathic gastroparesis?

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:

• Delayed gastric emptying
• Slow stomach emptying
• Gastric dysmotility
• Gastric stasis
• Lazy stomach

Qualified Participants Must:

• Age 18 or older
• Confirmed diagnosis of idiopathic gastroparesis
• Gastrointestinal symptoms within the last 6 months such as:

• Nausea or vomiting after eating
• Feeling too full after eating
• Bloating
• Throat or stomach pain

Qualified Participants May Receive:

$150 after each completed office visit

Office Pre-Screening Visit: $150

Office Screening: $150

Office Baseline GEBT4: $150

Office Randomization Visit: $150

Office Visit 4:  $150

Office Visit 5: $150

Office Visit 6: $150

Office Visit 7: $150

Office EOT (end of treatment) or ET (early termination): $150

Office EOS (End of Study) visit: $150

The amounts will be prorated if you do not complete all visits. You will be reimbursed only for completed office visits.

Additionally, for your time and inconvenience related to completion of the study diaries, you may be eligible to receive up to $275. The total you are eligible for will be decided based on the below:

·         $25 available for diary completion during the 14 days leading up to randomization.

·         $25 available for diary completion at each of the following visits: Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, and/or Visit 8

·         $50 available for 75% or more diaries completed prior to visit 5.

·         $50 available for 75% or more diaries completed prior to visit 7.