Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 6
months
- Negative upper endoscopy or upper radiographic GI series within 2 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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 12/15/23. Questions regarding updates should be directed to the study team contact.