Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
250 participants
Study Classification
OBSERVATIONAL
Study Start Date
2024-09-20
Study Completion Date
2027-04-30
Brief Summary
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The Gastroparesis Registry 4 (GpR4) is an observational study of patients with symptoms of gastroparesis (Gp) and functional dyspepsia (FD) with either delayed or normal gastric emptying. To better understand these disorders, this registry will capture demographic, clinical, physiological, questionnaire, and patient outcome data to characterize the patients and their clinical course. Participants will complete several questionnaires, complete a nutrient drink test and have a gastric emptying study.
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Detailed Description
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This observational study of patients with symptoms of gastroparesis (Gp) and functional dyspepsia (FD) with either delayed or normal gastric emptying aims to assess the clinical, pathophysiological, and psychological similarities and differences between patients with Gp, FD.
The primary outcome will be the measure of symptom severity of gastroparesis and functional dyspepsia using the change in total score from the Patient Assessment of Upper Gastrointestinal Disorders Symptoms (PAGI SYM) from baseline to 48 weeks.
The primary outcome will be the measure of symptom severity of gastroparesis and functional dyspepsia using the change in total score from the Patient Assessment of Upper Gastrointestinal Disorders Symptoms (PAGI SYM) from baseline to 48 weeks.
Conditions
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Gastroparesis
Gastroparesis Nondiabetic
Gastroparesis Due to Diabetes Mellitus Type I
Gastroparesis Due to Diabetes Mellitus Type II
Functional Disorder of Gastrointestinal Tract
Gastro-Intestinal Disorder
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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Gastroparesis
Gastroparesis symptoms with delayed emptying
No interventions assigned to this group
Functional Dyspepsia
Gastroparesis symptoms without delayed emptying
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age at least 18 years at initial screening visit
* Symptoms of Gp and/or FD of at least 12-weeks duration with varying degrees of nausea, vomiting, early satiety, postprandial fullness, abdominal pain, abdominal burning. Thus, patients can enter the GpR4 registry primarily with abdominal pain suggesting FD-Epigastric Pain Syndrome.
* Successful completion of gastric emptying scintigraphy of solids using the 4-hour Egg Beaters® protocol (or equivalent generic liquid egg white meal) within the last 9 months
* Negative upper endoscopy or upper radiographic GI series within 5 years of registration
* Symptoms of Gp and/or FD of at least 12-weeks duration with varying degrees of nausea, vomiting, early satiety, postprandial fullness, abdominal pain, abdominal burning. Thus, patients can enter the GpR4 registry primarily with abdominal pain suggesting FD-Epigastric Pain Syndrome.
* Successful completion of gastric emptying scintigraphy of solids using the 4-hour Egg Beaters® protocol (or equivalent generic liquid egg white meal) within the last 9 months
* Negative upper endoscopy or upper radiographic GI series within 5 years of registration
Exclusion Criteria
* Use of narcotic analgesics greater than three days per week
* Presence of other conditions that could explain the patient's symptoms such as:
* Pyloric or intestinal obstruction as evidenced by EGD, UGI, or Abdominal CT
* Active inflammatory bowel disease
* Known eosinophilic gastroenteritis or eosinophilic esophagitis
* Primary neurological conditions that can cause nausea and vomiting such as increased intracranial pressure, space occupying or inflammatory/infectious lesions
* Acute or chronic renal failure (serum creatinine \>3 mg/dL) and/or on hemodialysis or peritoneal dialysis
* Acute liver failure or advanced liver disease (Child's B or C; a Child-Pugh-Turcotte (CPT) score of ≥7)
* Pancreatic disorder if present on pancreatic imaging or pancreatic function testing
* Prior gastric surgery including total or subtotal (near complete) gastric resection, esophagectomy, gastrojejunostomy, gastric bypass, gastric sleeve, pyloroplasty, pyloromyotomy, or any fundoplication (Nissen, Tor)
* Any other condition, which in the opinion of the investigator, could explain the symptoms or interfere with study requirements
* Females who are pregnant. A urine pregnancy test is routinely obtained on all females immediately prior to gastric emptying procedures.
* Inability to comply with or complete the gastric emptying scintigraphy test (including allergy to eggs)
* Inability to obtain informed consent
* Presence of other conditions that could explain the patient's symptoms such as:
* Pyloric or intestinal obstruction as evidenced by EGD, UGI, or Abdominal CT
* Active inflammatory bowel disease
* Known eosinophilic gastroenteritis or eosinophilic esophagitis
* Primary neurological conditions that can cause nausea and vomiting such as increased intracranial pressure, space occupying or inflammatory/infectious lesions
* Acute or chronic renal failure (serum creatinine \>3 mg/dL) and/or on hemodialysis or peritoneal dialysis
* Acute liver failure or advanced liver disease (Child's B or C; a Child-Pugh-Turcotte (CPT) score of ≥7)
* Pancreatic disorder if present on pancreatic imaging or pancreatic function testing
* Prior gastric surgery including total or subtotal (near complete) gastric resection, esophagectomy, gastrojejunostomy, gastric bypass, gastric sleeve, pyloroplasty, pyloromyotomy, or any fundoplication (Nissen, Tor)
* Any other condition, which in the opinion of the investigator, could explain the symptoms or interfere with study requirements
* Females who are pregnant. A urine pregnancy test is routinely obtained on all females immediately prior to gastric emptying procedures.
* Inability to comply with or complete the gastric emptying scintigraphy test (including allergy to eggs)
* Inability to obtain informed consent
Minimum Eligible Age
18 Years
Maximum Eligible Age
85 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Texas Tech University Health Sciences Center, El Paso
OTHER
Sponsor Role
collaborator
Temple University
OTHER
Sponsor Role
collaborator
University of Louisville
OTHER
Sponsor Role
collaborator
Mayo Clinic
OTHER
Sponsor Role
collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Sponsor Role
collaborator
Massachusetts General Hospital
OTHER
Sponsor Role
collaborator
Wake Forest University
OTHER
Sponsor Role
collaborator
Johns Hopkins Bloomberg School of Public Health
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Jay Pasricha, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Henry Parkman, MD
Role: PRINCIPAL_INVESTIGATOR
Temple University
David Shade, JD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health
Locations
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Jay Pasricha
Scottsdale, Arizona, United States
Site Status
RECRUITING
University of Louisville
Louisville, Kentucky, United States
Site Status
RECRUITING
Massachusetts General Hospital
Boston, Massachusetts, United States
Site Status
RECRUITING
Wake Forest University and Atrium Health Carolinas Medical Center
Charlotte, North Carolina, United States
Site Status
RECRUITING
Temple University Hospital
Philadelphia, Pennsylvania, United States
Site Status
RECRUITING
Texas Tech University Health Science Center (TTUHSC)
El Paso, Texas, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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Baha Moshiree, MD
Role: primary
704-355-4593
References
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Hasler WL, Wilson LA, Parkman HP, Koch KL, Abell TL, Nguyen L, Pasricha PJ, Snape WJ, McCallum RW, Sarosiek I, Farrugia G, Calles J, Lee L, Tonascia J, Unalp-Arida A, Hamilton F. Factors related to abdominal pain in gastroparesis: contrast to patients with predominant nausea and vomiting. Neurogastroenterol Motil. 2013 May;25(5):427-38, e300-1. doi: 10.1111/nmo.12091. Epub 2013 Feb 17.
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Hasler WL, Wilson LA, Nguyen LA, Snape WJ, Abell TL, Koch KL, McCallum RW, Pasricha PJ, Sarosiek I, Farrugia G, Grover M, Lee LA, Miriel L, Tonascia J, Hamilton FA, Parkman HP; Gastroparesis Clinical Research Consortium. Opioid Use and Potency Are Associated With Clinical Features, Quality of Life, and Use of Resources in Patients With Gastroparesis. Clin Gastroenterol Hepatol. 2019 Jun;17(7):1285-1294.e1. doi: 10.1016/j.cgh.2018.10.013. Epub 2018 Oct 13.
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DiBaise JK, Patel N, Noelting J, Dueck AC, Roarke M, Crowell MD. The relationship among gastroparetic symptoms, quality of life, and gastric emptying in patients referred for gastric emptying testing. Neurogastroenterol Motil. 2016 Feb;28(2):234-42. doi: 10.1111/nmo.12718. Epub 2015 Nov 7.
Reference Type
BACKGROUND
Parkman HP, Hallinan EK, Hasler WL, Farrugia G, Koch KL, Calles J, Snape WJ, Abell TL, Sarosiek I, McCallum RW, Nguyen L, Pasricha PJ, Clarke J, Miriel L, Lee L, Tonascia J, Hamilton F; NIDDK Gastroparesis Clinical Research Consortium (GpCRC). Nausea and vomiting in gastroparesis: similarities and differences in idiopathic and diabetic gastroparesis. Neurogastroenterol Motil. 2016 Dec;28(12):1902-1914. doi: 10.1111/nmo.12893. Epub 2016 Jun 27.
Reference Type
BACKGROUND
Hasler WL, Wilson LA, Parkman HP, Nguyen L, Abell TL, Koch KL, Pasricha PJ, Snape WJ, Farrugia G, Lee L, Tonascia J, Unalp-Arida A, Hamilton F; NIDDK Gastroparesis Clinical Research Consortium (GpCRC). Bloating in gastroparesis: severity, impact, and associated factors. Am J Gastroenterol. 2011 Aug;106(8):1492-502. doi: 10.1038/ajg.2011.81. Epub 2011 Apr 12.
Reference Type
BACKGROUND
Abell TL, Bernstein RK, Cutts T, Farrugia G, Forster J, Hasler WL, McCallum RW, Olden KW, Parkman HP, Parrish CR, Pasricha PJ, Prather CM, Soffer EE, Twillman R, Vinik AI. Treatment of gastroparesis: a multidisciplinary clinical review. Neurogastroenterol Motil. 2006 Apr;18(4):263-83. doi: 10.1111/j.1365-2982.2006.00760.x.
Reference Type
BACKGROUND
Pasricha PJ, Camilleri M, Hasler WL, Parkman HP. White Paper AGA: Gastroparesis: Clinical and Regulatory Insights for Clinical Trials. Clin Gastroenterol Hepatol. 2017 Aug;15(8):1184-1190. doi: 10.1016/j.cgh.2017.04.011. Epub 2017 Apr 12.
Reference Type
BACKGROUND
Parkman HP, Yates KP, Hasler WL, Nguyan L, Pasricha PJ, Snape WJ, Farrugia G, Calles J, Koch KL, Abell TL, McCallum RW, Petito D, Parrish CR, Duffy F, Lee L, Unalp-Arida A, Tonascia J, Hamilton F; NIDDK Gastroparesis Clinical Research Consortium. Dietary intake and nutritional deficiencies in patients with diabetic or idiopathic gastroparesis. Gastroenterology. 2011 Aug;141(2):486-98, 498.e1-7. doi: 10.1053/j.gastro.2011.04.045. Epub 2011 Apr 28.
Reference Type
BACKGROUND
Parkman HP, Yates K, Hasler WL, Nguyen L, Pasricha PJ, Snape WJ, Farrugia G, Koch KL, Abell TL, McCallum RW, Lee L, Unalp-Arida A, Tonascia J, Hamilton F; National Institute of Diabetes and Digestive and Kidney Diseases Gastroparesis Clinical Research Consortium. Clinical features of idiopathic gastroparesis vary with sex, body mass, symptom onset, delay in gastric emptying, and gastroparesis severity. Gastroenterology. 2011 Jan;140(1):101-15. doi: 10.1053/j.gastro.2010.10.015. Epub 2010 Oct 20.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB00401119
Identifier Type: OTHER
Identifier Source: secondary_id
14-DK-GpR4
Identifier Type: -
Identifier Source: org_study_id
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