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Completed

NCT Number: NCT00398801

Gastroparesis Registry

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

California Pacific Medical Center, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: GpR

Important dates

Study start
2006
Primary completion
2010
Study completion
2011
First posted
Nov 14, 2006
Registry last updated
Feb 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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