Gastroparesis Registry (GpR)
This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00398801
First received: November 13, 2006
Last updated: September 27, 2012
Last verified: September 2012
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Purpose
The Gastroparesis Registry (GpR) is an observational study to clarify the epidemiology, natural history, clinical course, and other outcomes of gastroparesis.
| Condition |
|---|
|
Gastroparesis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Gastroparesis Registry |
Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Biospecimen Retention: Samples With DNA
Detailed Description:
Plasma and serum
| Enrollment: | 591 |
| Study Start Date: | December 2006 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Tertiary care centers for patients with symptoms of gastroparesis
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00398801
Locations
| United States, California | |
| California Pacific Medical Center | |
| San Francisco, California, United States, 94115 | |
| Stanford University | |
| Stanford, California, United States, 94305-5187 | |
| United States, Michigan | |
| University of Michigan Medical Center | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216 | |
| United States, North Carolina | |
| Wake Forest University Health Sciences | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Pennsylvania | |
| Temple University Hospital | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| United States, Texas | |
| Texas Tech University Health Science Center (TTUHSC) | |
| El Paso, Texas, United States, 79905 | |
Sponsors and Collaborators
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 |
| Principal Investigator: | Richard W McCallum, MD | Texas Tech University Health Science Center |
More Information
Additional Information:
No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00398801 History of Changes |
| Other Study ID Numbers: | IND - DK74008 |
| Study First Received: | November 13, 2006 |
| Last Updated: | September 27, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
|
gastroparesis |
Additional relevant MeSH terms:
|
Gastroparesis Stomach Diseases Gastrointestinal Diseases Digestive System Diseases |
Paralysis Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013