Ignite Creation Date:
2024-05-06 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 12:54 PM
Study NCT ID:
NCT03680859
Status:
COMPLETED
Last Update Posted:
2024-05-24
First Post:
2018-09-07
Brief Title:
Gastroparesis Registry 3
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
The NIDDK Gastroparesis Registry 3 Characterization and Clinical Course of Symptoms and Gastric Emptying in Patients With Symptoms of Gastroparesis
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GpR3
Brief Summary:
The purpose of this study is to create a new registry of patients with gastroparesis in order to better understand the characteristics of patients with gastroparesis and follow how their condition changes over time The data collected may improve the understanding of the condition to enable better diagnosis and treatment
Detailed Description:
GpR 3 is an observational study of patients with symptoms of gastroparesis with either delayed or normal gastric emptying Epidemiological clinical physiological and patient outcome data will be collected to characterize the patients and their clinical course to better understand this disorder The long-term goal is to help phenotype patients into pathophysiologically defined subsets This classification will provide a foundation for translational research facilitating the search for etiopathogenesis and enhance the ability to define and conduct large clinical trials ultimately leading to the development of more rational and effective therapeutic approaches for gastroparesis
The primary objectives of the Gastroparesis Registry 3 GpR 3 are
To create a new registry of patients with symptoms of gastroparesis both patients with delayed gastric emptying and patients with similar symptoms but normal gastric emptying for the enhanced study of symptoms gastric motility abnormalities patient characteristics and degree of morbidity
To follow a well-characterized cohort to further define the natural history and clinical course of patients with symptoms of gastroparesis - both symptoms and gastric emptying over time Treatments given for their clinical care and clinical responses to treatments will be recorded
To provide a reliable source for recruitment of well-characterized patients with gastroparesis for other studies including therapeutic clinical trials pathophysiological molecular histopathologic or other ancillary studies These subsequent clinical trials or ancillary studies will be conducted under separate study protocols with separate consent processes
Specific secondary objectives of GpR3 have been developed to allow the patients entered in GpR3 to help advance our understanding of gastroparesis
Assess several areas of gastric motility in patients with symptoms of gastroparesis fundic accommodation antral contractility global gastric emptying
Determine the change in gastric motility over time in patients with gastroparesis and in patients with symptoms of gastroparesis but normal gastric emptying
Evaluate the clinical symptomatic course outcome of patients followed in the registry
Use the registry to better capture clinical treatment responses to specific treatments while patients are in the registry
Characterize abdominal pain in patients with gastroparesis and gastroparesis-like syndrome by
Describing the abdominal pain seen in patients with gastroparesis
Determining if the pain has neuropathic or nociceptive qualities
Determining attributes of patients with abdominal pain
Assessing patients in the presence of sensory gastric dysfunction
Objective mapping of the abdominal pain and determining central andor peripheral attributes of the abdominal pain
Compare the Rome IV categories of gastric disorders functional dyspepsia FD epigastric pain syndrome EPS postprandial distress syndrome PDS chronic idiopathic nausea and vomiting CINV rumination syndrome cyclic vomiting syndrome central abdominal pain syndrome to our present classification of gastroparesis and gastroparesis-like disorder
Determine the prevalence of hypermobility spectrum disorders HSD in patients with gastroparesis
Compare the water load satiety test WLST to intragastric meal distribution IMD during scintigraphy and to symptoms of early satiety postprandial fullness in patients with symptoms of gastroparesis
Collect serum plasma and peripheral blood mononuclear cells PBMC that can be used for subsequent analysis to address specific research questions
The primary objectives of the Gastroparesis Registry 3 GpR 3 are
To create a new registry of patients with symptoms of gastroparesis both patients with delayed gastric emptying and patients with similar symptoms but normal gastric emptying for the enhanced study of symptoms gastric motility abnormalities patient characteristics and degree of morbidity
To follow a well-characterized cohort to further define the natural history and clinical course of patients with symptoms of gastroparesis - both symptoms and gastric emptying over time Treatments given for their clinical care and clinical responses to treatments will be recorded
To provide a reliable source for recruitment of well-characterized patients with gastroparesis for other studies including therapeutic clinical trials pathophysiological molecular histopathologic or other ancillary studies These subsequent clinical trials or ancillary studies will be conducted under separate study protocols with separate consent processes
Specific secondary objectives of GpR3 have been developed to allow the patients entered in GpR3 to help advance our understanding of gastroparesis
Assess several areas of gastric motility in patients with symptoms of gastroparesis fundic accommodation antral contractility global gastric emptying
Determine the change in gastric motility over time in patients with gastroparesis and in patients with symptoms of gastroparesis but normal gastric emptying
Evaluate the clinical symptomatic course outcome of patients followed in the registry
Use the registry to better capture clinical treatment responses to specific treatments while patients are in the registry
Characterize abdominal pain in patients with gastroparesis and gastroparesis-like syndrome by
Describing the abdominal pain seen in patients with gastroparesis
Determining if the pain has neuropathic or nociceptive qualities
Determining attributes of patients with abdominal pain
Assessing patients in the presence of sensory gastric dysfunction
Objective mapping of the abdominal pain and determining central andor peripheral attributes of the abdominal pain
Compare the Rome IV categories of gastric disorders functional dyspepsia FD epigastric pain syndrome EPS postprandial distress syndrome PDS chronic idiopathic nausea and vomiting CINV rumination syndrome cyclic vomiting syndrome central abdominal pain syndrome to our present classification of gastroparesis and gastroparesis-like disorder
Determine the prevalence of hypermobility spectrum disorders HSD in patients with gastroparesis
Compare the water load satiety test WLST to intragastric meal distribution IMD during scintigraphy and to symptoms of early satiety postprandial fullness in patients with symptoms of gastroparesis
Collect serum plasma and peripheral blood mononuclear cells PBMC that can be used for subsequent analysis to address specific research questions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U24DK074008 | NIH | None | httpsreporternihgovquickSearchU24DK074008 |
| U01DK073983 | NIH | None | None |
| U01DK112193 | NIH | None | None |
| U01DK073975 | NIH | None | None |
| U01DK074035 | NIH | None | None |
| U01DK074007 | NIH | None | None |
| U01DK073974 | NIH | None | None |