Gastroparesis Registry 2

Gastroparesis Clinical Trial

— GpR2  

Official title:

GpR 2: Continuation of the NIDDK Gastroparesis Registry for the Characterization and Clinical Course of Gastroparesis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01696747
• Other study ID #: GpCRC-GpR 2-5
• Secondary ID: U01DK073974U01DK
• Status: Completed
• Start date: July 2012
• Est. completion date: April 30, 2019

Study information

• Verified date: February 2022
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To expand a registry of patients for the study of the epidemiology, etiology, and degree of morbidity associated with gastroparesis.

Description:

The Gastroparesis Registry 2 (GpR 2) will enroll new patients and patients from the initial NIDDK Gastroparesis Clinical Research Consortium Gastroparesis Registry (GpR) of gastroparesis patients which was initiated in February 2007 and completed in March 2011.

To continue to follow and expand the data collections of a well-characterized cohort to further define the natural history and clinical course of gastroparesis.

To provide a reliable source for recruitment of well-characterized patients with gastroparesis for therapeutic clinical trials, pathophysiological, molecular, histopathologic, or other ancillary studies. These subsequent clinical trials or ancillary studies will be conducted under separate study protocols with separate consent processes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 506
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Symptoms of gastroparesis of at least 12 weeks duration (do not have to be contiguous) with varying degrees of nausea, vomiting, early satiety, post-prandial fullness, and/or abdominal pain

• An etiology of either diabetic, idiopathic, or post-Nissen fundoplication gastroparesis

• Gastric emptying scintigraphy of solids and liquids test using 4 hours Egg Beaters® protocol within the last 6 months with either:

• Abnormal gastric emptying rate defined as an abnormal 2 hour (>60% retention) and/or 4 hour (>10% retention) result based on a 4-hour scintigraphic low fat Egg Beaters® gastric emptying study performed at a GpCRC clinical center.

• Patients with a normal gastric emptying rate but with symptoms of gastroparesis may be enrolled and classified as possible gastroparesis or gastroparesis-like with normal gastric emptying

• Age at least 18 years at initial screening visit

• Upper endoscopy results within last 2 years

Exclusion Criteria:

• Inability to comply with or complete the gastric emptying scintigraphy test (including allergy to eggs)

• Presence of other conditions that could explain the patient's symptoms:

• Pyloric or intestinal obstruction as determined by endoscopy, upper GI series or abdominal CT scan

• Active inflammatory bowel disease

• Known eosinophilic gastroenteritis

• Primary neurological conditions that could cause nausea and/or vomiting such as increased intracranial pressure, space occupying or inflammatory/infectious lesions

• Acute liver failure

• Advanced liver disease (Child's B or C; a Child-Pugh-Turcotte (CPT) score of =7 )

• Acute renal failure

• Chronic renal failure (serum creatinine >3 mg/dL) and/or on hemodialysis or peritoneal dialysis

• Total or subtotal (near complete) gastric resection, esophagogastrostomy, gastrojejunostomy, or gastric bypass. Note: patients with prior fundoplication will be eligible for enrollment.

• Any other plausible structural or metabolic cause

• Any other condition, which in the opinion of the investigator would interfere with study requirements

• Inability to obtain informed consent

Related Conditions & MeSH terms

• Diabetic Gastroparesis
• Gastroparesis
• Idiopathic Gastroparesis

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	Massachusetts General Hospital-Digestive Healthcare Center	Boston	Massachusetts
United States	Texas Tech University Health Sciences Center	El Paso	Texas
United States	University of Louisville	Louisville	Kentucky
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

External Links

•   Gastroparesis Clinical Research Consortium