Gastroparesis Registry - Tabular View

Tracking Information

First Received Date ^ICMJE

November 13, 2006

Last Updated Date

July 7, 2009

Start Date ^ICMJE

December 2006

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00398801 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Gastroparesis Registry

Official Title ^ICMJE

Gastroparesis Registry

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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Prospective

Condition ^ICMJE

Gastroparesis

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

500

Completion Date

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00398801

Responsible Party

Frank Hamilton, PhD, National Institute of Diabetes and Digestive and Kidney Diseases

Study ID Numbers ^ICMJE

DK74008

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	James Tonascia, PhD	Johns Hopkins University Bloomberg School of Public Health
Principal Investigator:	Henry P Parkman, MD	Temple University Hospital
Principal Investigator:	William L Hasler, MD	University of Michigan
Principal Investigator:	Thomas L Abell, MD	University of Mississippi Medical Center
Principal Investigator:	Pankaj J Pasricha, MD	Stanford University
Principal Investigator:	Kenneth L Koch, MD	Wake Forest University
Principal Investigator:	Richard W McCallum, MD	University of Kansas

Information Provided By

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

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP