Gastroparesis Registry

Gastroparesis Clinical Trial

— GpR  

Official title:

Gastroparesis Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00398801
• Other study ID #: U01DK074008 GpR
• Secondary ID: U01DK074008
• Status: Completed
• Start date: December 2006
• Est. completion date: March 2011

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

The Gastroparesis Registry (GpR) is an observational study to clarify the epidemiology, natural history, clinical course, and other outcomes of gastroparesis.

Description:

The Gastroparesis Registry (GpR) is an observational study to clarify the epidemiology, natural history, clinical course, and other outcomes of gastroparesis. The Gastroparesis Registry will also provide a resource to inform the development of clinical trials and ancillary studies of the epidemiology, etiology, pathophysiology, and impact of gastroparesis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 591
• Est. completion date: March 2011
• Est. primary completion date: March 2010
• 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, abdominal pain, early satiety, post-prandial fullness,

• Completion of a 4-hour scintigraphic low fat Egg Beaters gastric emptying study

• Patients with either or both abnormal 2 hour (>60% retention) and 4 hour (>10% retention) gastric emptying will be enrolled and classified as definite gastroparesis (Gp)

• Patients with normal gastric emptying, but with symptoms of gastroparesis may be enrolled and classified as possible gastroparesis or gastroparesis-like with normal gastric emptying (GLNGE)

• Age at least 18 years at initial screening visit

• Ability and willingness to participate in follow-up

Exclusion Criteria:

• Inability to comply with or complete the gastric emptying scintigraphy

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

• Pyloric or intestinal obstruction

• Active inflammatory bowel disease

• Eosinophilic gastroenteritis

• Neurological conditions such as increased intracranial pressure, space occupying or inflammatory/infectious lesions

• Acute liver failure

• Advanced liver disease (Child's B or C)

• Acute renal failure

• Untreated chronic renal failure (serum creatinine >3 mg/dL)

• Total or subtotal gastric resection (patients with prior fundoplication or postvagotomy gastroparesis after pyloroplasty or antrectomy with Billroth I, Billroth II, or Roux-en-Y gastrojejunostomy 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

• Gastroparesis

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	Texas Tech University Health Science Center (TTUHSC)	El Paso	Texas
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	California Pacific Medical Center	San Francisco	California
United States	Stanford University	Stanford	California
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, 

References & Publications (1)

Parkman HP, Yates K, Hasler WL, Nguyen L, Pasricha PJ, Snape WJ, Farrugia G, Koch KL, Calles J, Abell TL, Sarosiek I, McCallum RW, Lee L, Unalp-Arida A, Tonascia J, Hamilton F. Cholecystectomy and clinical presentations of gastroparesis. Dig Dis Sci. 2013 — View Citation

External Links

•   Gastroparesis Clinical Research Consortium
•   National Institute of Diabetes and Digestive and Kidney Diseases