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 @ 3:39 AM
Ignite Modification Date:
2025-12-25 @ 3:39 AM
NCT ID:
NCT05846802
Eligibility Criteria:
Inclusion Criteria:
* Age at least 18 years at initial screening visit
* Symptoms of Gp and/or FD of at least 12-weeks duration with varying degrees of nausea, vomiting, early satiety, postprandial fullness, abdominal pain, abdominal burning. Thus, patients can enter the GpR4 registry primarily with abdominal pain suggesting FD-Epigastric Pain Syndrome.
* Successful completion of gastric emptying scintigraphy of solids using the 4-hour Egg Beaters® protocol (or equivalent generic liquid egg white meal) within the last 9 months
* Negative upper endoscopy or upper radiographic GI series within 5 years of registration
Exclusion Criteria:
* Use of narcotic analgesics greater than three days per week
* Presence of other conditions that could explain the patient's symptoms such as:
* Pyloric or intestinal obstruction as evidenced by EGD, UGI, or Abdominal CT
* Active inflammatory bowel disease
* Known eosinophilic gastroenteritis or eosinophilic esophagitis
* Primary neurological conditions that can cause nausea and vomiting such as increased intracranial pressure, space occupying or inflammatory/infectious lesions
* Acute or chronic renal failure (serum creatinine \>3 mg/dL) and/or on hemodialysis or peritoneal dialysis
* Acute liver failure or advanced liver disease (Child's B or C; a Child-Pugh-Turcotte (CPT) score of ≥7)
* Pancreatic disorder if present on pancreatic imaging or pancreatic function testing
* Prior gastric surgery including total or subtotal (near complete) gastric resection, esophagectomy, gastrojejunostomy, gastric bypass, gastric sleeve, pyloroplasty, pyloromyotomy, or any fundoplication (Nissen, Tor)
* Any other condition, which in the opinion of the investigator, could explain the symptoms or interfere with study requirements
* Females who are pregnant. A urine pregnancy test is routinely obtained on all females immediately prior to gastric emptying procedures.
* Inability to comply with or complete the gastric emptying scintigraphy test (including allergy to eggs)
* Inability to obtain informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05846802
Study Brief:
Protocol Section:
NCT05846802