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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT00702533
Eligibility Criteria:
* CURRENTLY ONLY RECRUITING Patients with Zollinger Ellison Syndrome and Hypersecretion AND Patients with Refractory GERD, Peptic ulcer disease, Idiopathic Gastric Hypersecretion
Phase II, Use in Patients with Zollinger Ellison Syndrome and Hypersecretion
INCLUSION:
* Zollinger-Ellison syndrome (ZES) as diagnosed by one of the following criteria: histologic confirmation of gastrinoma, positive provocative testing with secretin (an increase of \>200 pg/mL postinjection), gastric acid hypersecretion (BAO \> 15) in the presence of hypergastrinemia (fasting serum gastrin \> 99)
* Multiple endocrine neoplasia type-I (MEN1) with suspicion of ZES (hypergastrinemia) undergoing evaluation. MEN-I with ZES
* Hypergastrinemia (serum gastrin \> 99)
Patients must meet at least 1 of the above inclusion criteria and the following:
* Ages equal to or greater than 18 years
* Male, females, all ethnicities
EXCLUSION:
* History of gastric surgery (gastrectomy, pyloroplasty)
* Use of bowel motility medications such as, but not limited to, Reglan, Immodium, and Lomotil
* Contraindication to SmartPill: history of gastric bezoar, disorders of swallowing, suspected strictures, fistulas, or physiological GI obstruction, GI surgery within the past three months, severe dysphagia to food or pills, Crohn s Disease or diverticulitis, a subject who uses an implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump
* Pregnancy and breastfeeding. Females of childbearing potential must be on an acceptable means of birth control and no intercourse in 2 weeks prior to study enrollment.
* Lactose intolerance or inability to drink standard meal of Ensure Plus
* Estabished diagnosis of gastroparesis
* Significant systemic or major illnesses including, but not limited to, stroke, congestive heart failure, renal failure (creatinine clearance \< 50 ml/min), organ transplantation, angina pectoris, active malignancy, and autonomic neuropathy
* Unstable psychiatric conditions, untreated or uncontrolled depression or generalized anxiety disorder, substance abuse within the past year, in order to prevent feeling of being uncomfortable or to prevent lack of follow-up
* Use of not-steroidal anti-inflammatory drugs for 2 weeks prior to study enrollment
Phase IIIA, Use in Patients with Refractory GERD, Peptic ulcer disease, Idiopathic Gastric Hypersecretion
INCLUSION:
* Gastric acid hypersecretion (BAO\>15 mEq/hr)
* Conditions with gastric acid hypersecretion including, but not limited to, patients with systemic mastocytosis (SM)
* Refractory GERD (patients with persistant symptoms despite being on standard medical therapy), PUD, and suspected idiopathic gastric hypersecretion
Patients must meet at least 1 of the above inclusion criteria and the following:
* Ages equal to or greater than 18 years
* Male, females, all ethnicities
EXCLUSION:
* History of gastric surgery (gastrectomy, pyloroplasty).
* Use of bowel motility medications such as, but not limited to, Reglan, Immodium, and Lomotil
* Contraindication to SmartPill: history of gastric bezoar, disorders of swallowing, suspected strictures, fistulas, or physiological GI obstruction, GI surgery within the past three months, severe dysphagia to food or pills, Crohn s Disease or diverticulitis, a subject who uses an implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump
* Pregnancy and breastfeeding. Females of childbearing potential must be on an acceptable means of birth control and no intercourse in 2 weeks prior to study enrollment.
* Lactose intolerance or inability to drink standard meal of Ensure Plus
* Established diagnosis of gastroparesis
* Significant systemic or major illnesses including, but not limited to, stroke, congestive heart failure, renal failure (creatinine clearance \< 50 ml/min), organ transplantation, angina pectoris, active malignancy, and autonomic neuropathy
* Unstable psychiatric conditions, untreated or uncontrolled depression or generalized anxiety disorders, substance abuse within the past year, in order to prevent feeling of being uncomfortable or to prevent lack of follow-up. Use of non-steroidal anti-inflammatory drugs for 2 weeks prior to study enrollment.
Phase IIIB, Use in Patients with Medication-Controlled: GERD, Peptic ulcer disease, Idiopathic Gastric Hypersecretion
INCLUSION:
-Medication-controlled (patients whose symptoms resolve with medication):GERD, PUD, and suspected idiopathic gastric hypersecretion
Patients must meet the above inclusion criteria and the following
* Ages equal to or greater than 18 years
* Male, females, all ethnicities
EXCLUSION:
* Refractory to medication: GERD (patients with persistant symptoms despite being on standard medical therapy), PUD, and suspected idiopathic gastric hypersecretion
* History of gastric surgery (gastrectomy, pyloroplasty).
* Use of bowel motility medications such as, but not limited to, Reglan, Immodium, and Lomotil
* Contraindication to SmartPill: history of gastric bezoar, disorders of swallowing, suspected strictures, fistulas, or physiological GI obstruction, GI surgery within the past three months, severe dysphagia to food or pills, Crohn s Disease or diverticulitis, a subject who uses an implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump
* Pregnancy and breastfeeding. Females of childbearing potential must be on an acceptable means of birth control and no intercourse in 2 weeks prior to study enrollment.
* Lactose intolerance or inability to drink standard meal of Ensure Plus
* Established diagnosis of gastroparesis
* Significant systemic or major illnesses including, but not limited to, stroke, congestive heart failure, renal failure (creatinine clearance \< 50 ml/min), organ transplantation, angina pectoris, active malignancy, and autonomic neuropathy
* Unstable psychiatric conditions, untreated or uncontrolled depression or genralized anxiety disorders, substance abuse within the past year, in order to prevent feeling of being uncomfortable or to prevent lack of follow-up
* Use of non-steroidal anti-inflammatory drugs for 2 weeks prior to study enrollment
RECRUITMENT IS CLOSED FOR Phase IA/IB, Validation and Establishment of Nomogram in Healthy Volunteers
PHASE IA/IB INCLUSION:
* Healthy volunteers
* Ages 18-60
* Males, females, all ethnicities
PHASE IA/IB EXCLUSION:
* History of gastric or bowel surgery
* Use of bowel motility medications such as, but not limited to, Reglan, Immodium, and Lomotil
* Use of antacid, antisecretory, and anticholinergic medications such as, but not limited to, proton pump inhibitors and histamine 2 receptor antagonists
* Use of non-steroidal anti-inflammatory drugs for 2 weeks prior to study enrollment
* Hypersecretory and hyposecretory related conditions including, but not limited to, pernicious anemia, atrophic gastritis, and Zollinger-Ellison syndrome
* Contraindication to NGT: deviated septum, history of transphenoidal surgery, chronic sinusitis, severe facial trauma (cribriform plate disruption, sustained head trauma, maxillofacial injury, or anterior fossa skull fracture), esophageal stricture, esophageal varices, altered mental status, and impaired airway
* Contraindication to scintigraphy: allergy to sulfa-colloid
* Contraindication to pentagastrin: allergy to pentagastrin, active gastrointestinal bleeding, active peptic ulcer disease, active gallbladder and liver disease, pancreatitis, and bowel obstruction
* Contraindication to SmartPill: history of gastric bezoar, disorders of swallowing, suspected strictures, fistulas, or physiological GI obstruction, GI surgery within the past three months, severe dysphagia to food or pills, Crohns disease or diverticulosis, and implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump
* Pregnancy and breastfeeding. Females of childbearing potential must be on an acceptable means of birth control and no intercourse in 2 weeks prior to study enrollment.
* Lactose intolerance or inability to drink standard meal of Ensure Plus
* Helicobacter pylori infection
* Gastroparesis
* History of gastroesophageal reflux disease, peptic ulcer disease, irritable bowel syndrome, or inflammatory bowel disease
* Significant systemic or major illnesses including, but not limited to, stroke, cardiovascular disease, hypertension, congestive heart failure, renal failure (creatinine clearance \< 50 ml/min), organ transplantation, angina pectoris, active malignancy, diabetes, or autonomic neuropathy
* Unstable psychiatric conditions, depression, generalized anxiety disorder, or substance abuse within the past year, in order to prevent feeling of being uncomfortable or to prevent lack of follow-up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00702533
Study Brief:
Protocol Section:
NCT00702533