Skip to content

Gastroparesis Registry

Gastroparesis Registry

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00398801
Acronym
GpR
Enrollment
591
Registered
2006-11-14
Start date
2006-12-31
Completion date
2011-03-31
Last updated
2022-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroparesis

Keywords

gastroparesis

Brief summary

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

Detailed 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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026