Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT02187094
Eligibility Criteria:
Inclusion Criteria:
* A diagnosis of gastroparesis or symptoms consistent with gastroparesis for at least 6 months (and Gastroparesis Cardinal Symptoms Index total score \>22)
* Gastroparesis confirmed using the GEBT
* Type 1 or Type 2 diabetes with a Hemoglobin A1c ≤ 10%
* Fasting blood glucose (finger stick) ≤ 275 mg/dL prior to each GEBT
* Body Mass Index (BMI) ≤ 40
* Willingness to remain in clinical research facility for the protocol-required days of treatment and study procedures
* Willingness to use a double barrier method of birth control (except post-menopausal females)
* Able to understand study procedures and provide written informed consent
Exclusion Criteria:
* History of abdominal surgery including gastric banding procedure
* Chronic parenteral feeding or feeding through a gastrostomy or jejunostomy tube
* Persistent daily vomiting
* A history of eating disorder
* Recent history of poor control of diabetes
* Acute severe gastroenteritis
* Have implanted or use any type of gastric electric stimulator
* Use of opiates, anticholinergic medications, GLP-1 mimetics or amylin analogs
* Use of medications potentially influencing upper gastrointestinal motility or appetite
* Allergies or intolerance to egg, wheat, milk, or algae
* Pregnant or lactating females
* Presence of a clinically significant medical condition at any time during the study
* Presence of clinically significant abnormalities in laboratory findings, physical exam findings or vital signs
* Participated in an investigational drug study within 30 days of screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02187094
Study Brief:
Protocol Section:
NCT02187094