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GpR: Gastroparesis Registry

Sponsor
Johns Hopkins Bloomberg School of Public Health (Other)
Overall Status
Completed
CT.gov ID
NCT00398801
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
591
Enrollment
7
Locations
51
Actual Duration (Months)
84.4
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    591 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Gastroparesis Registry
    Actual Study Start Date :
    Dec 1, 2006
    Actual Primary Completion Date :
    Mar 1, 2010
    Actual Study Completion Date :
    Mar 1, 2011

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts 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

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 California Pacific Medical Center San Francisco California United States 94115
      2 Stanford University Stanford California United States 94305-5187
      3 University of Michigan Medical Center Ann Arbor Michigan United States 48109
      4 University of Mississippi Medical Center Jackson Mississippi United States 39216
      5 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
      6 Temple University Hospital Philadelphia Pennsylvania United States 19140
      7 Texas Tech University Health Science Center (TTUHSC) El Paso Texas United States 79905

      Sponsors and Collaborators

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

      Investigators

      • 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 Health Sciences
      • Principal Investigator: Richard W McCallum, MD, Texas Tech University Health Science Center

      Study Documents (Full-Text)

      None provided.

      More Information

      Additional Information:

      Publications

      None provided.
      Responsible Party:
      Johns Hopkins Bloomberg School of Public Health
      ClinicalTrials.gov Identifier:
      NCT00398801
      Other Study ID Numbers:
      • U01DK074008 GpR
      • U01DK074008
      First Posted:
      Nov 14, 2006
      Last Update Posted:
      Feb 23, 2022
      Last Verified:
      Feb 1, 2022
      Individual Participant Data (IPD) Sharing Statement:
      Yes
      Plan to Share IPD:
      Yes
      Studies a U.S. FDA-regulated Drug Product:
      No
      Studies a U.S. FDA-regulated Device Product:
      No
      Keywords provided by Johns Hopkins Bloomberg School of Public Health
      gastroparesis
      Additional relevant MeSH terms:
      Gastroparesis

      Study Results

      No Results Posted as of Feb 23, 2022