Phase
Condition
Ulcers
Diabetes Prevention
Gastrointestinal Diseases And Disorders
Treatment
N/AClinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 ofnausea, vomiting, early satiety, postprandial fullness, abdominal pain, abdominalburning. Thus, patients can enter the GpR4 registry primarily with abdominal painsuggesting FD-Epigastric Pain Syndrome.
Successful completion of gastric emptying scintigraphy of solids using the 4-hourEgg 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 ofregistration
Exclusion
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 increasedintracranial pressure, space occupying or inflammatory/infectious lesions
Acute or chronic renal failure (serum creatinine >3 mg/dL) and/or on hemodialysis orperitoneal 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 thesymptoms or interfere with study requirements
Females who are pregnant. A urine pregnancy test is routinely obtained on allfemales 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
Study Design
Study Description
Connect with a study center
Jay Pasricha
Scottsdale, Arizona 85259
United StatesActive - Recruiting
University of Louisville
Louisville, Kentucky 40202
United StatesActive - Recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Wake Forest University and Atrium Health Carolinas Medical Center
Charlotte, North Carolina 28202
United StatesActive - Recruiting
Kenneth Koch
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Temple University Hospital
Philadelphia, Pennsylvania 19140
United StatesActive - Recruiting
Texas Tech University Health Science Center (TTUHSC)
El Paso, Texas 79905
United StatesActive - Recruiting
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