Gastroparesis Registry 4

Gastroparesis Clinical Trial

— GpR4  

Official title:

Gastroparesis Registry 4 (GpR4): Improving the Understanding of Gastroparesis and Functional Dyspepsia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05846802
• Other study ID #: 14-DK-GpR4
• Secondary ID: U01DK073975U01DK
• Status: Not yet recruiting
• Start date: June 30, 2024
• Est. completion date: April 30, 2027

Study information

• Verified date: May 2024
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: Laura Miriel
• Phone: 4435024165
• Email: lmiriel1[@]jhu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: April 30, 2027
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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 6 months

• Negative upper endoscopy or upper radiographic GI series within 2 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Digestive System Diseases
• Gastro-Intestinal Disorder
• Gastrointestinal Diseases
• Gastroparesis
• Intestinal Diseases

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Wake Forest University and Atrium Health Carolinas Medical Center	Charlotte	North Carolina
United States	Texas Tech University Health Science Center (TTUHSC)	El Paso	Texas
United States	University of Louisville	Louisville	Kentucky
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Jay Pasricha	Scottsdale	Arizona

Sponsors (8)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Massachusetts General Hospital, Mayo Clinic, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Temple University, Texas Tech University Health Sciences Center, El Paso, University of Louisville, Wake Forest University

Country where clinical trial is conducted

United States, 

References & Publications (54)

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. — View Citation

Abell TL, Camilleri M, Donohoe K, Hasler WL, Lin HC, Maurer AH, McCallum RW, Nowak T, Nusynowitz ML, Parkman HP, Shreve P, Szarka LA, Snape WJ Jr, Ziessman HA; American Neurogastroenterology and Motility Society and the Society of Nuclear Medicine. Consensus recommendations for gastric emptying scintigraphy: a joint report of the American Neurogastroenterology and Motility Society and the Society of Nuclear Medicine. Am J Gastroenterol. 2008 Mar;103(3):753-63. doi: 10.1111/j.1572-0241.2007.01636.x. Epub 2007 Nov 19. — View Citation

Abell TL, Yamada G, McCallum RW, Van Natta ML, Tonascia J, Parkman HP, Koch KL, Sarosiek I, Farrugia G, Grover M, Hasler W, Nguyen L, Snape W, Kuo B, Shulman R, Hamilton FA, Pasricha PJ. Effectiveness of gastric electrical stimulation in gastroparesis: Results from a large prospectively collected database of national gastroparesis registries. Neurogastroenterol Motil. 2019 Dec;31(12):e13714. doi: 10.1111/nmo.13714. Epub 2019 Oct 4. — View Citation

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Chial HJ, Camilleri C, Delgado-Aros S, Burton D, Thomforde G, Ferber I, Camilleri M. A nutrient drink test to assess maximum tolerated volume and postprandial symptoms: effects of gender, body mass index and age in health. Neurogastroenterol Motil. 2002 Jun;14(3):249-53. doi: 10.1046/j.1365-2982.2002.00326.x. — View Citation

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Glissen Brown JR, Bernstein GR, Friedenberg FK, Ehrlich AC. Chronic Abdominal Wall Pain: An Under-Recognized Diagnosis Leading to Unnecessary Testing. J Clin Gastroenterol. 2016 Nov/Dec;50(10):828-835. doi: 10.1097/MCG.0000000000000636. — View Citation

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Grover M, Farrugia G, Lurken MS, Bernard CE, Faussone-Pellegrini MS, Smyrk TC, Parkman HP, Abell TL, Snape WJ, Hasler WL, Unalp-Arida A, Nguyen L, Koch KL, Calles J, Lee L, Tonascia J, Hamilton FA, Pasricha PJ; NIDDK Gastroparesis Clinical Research Consortium. Cellular changes in diabetic and idiopathic gastroparesis. Gastroenterology. 2011 May;140(5):1575-85.e8. doi: 10.1053/j.gastro.2011.01.046. Epub 2011 Feb 4. — View Citation

Hasler WL, Parkman HP, Wilson LA, Pasricha PJ, Koch KL, Abell TL, Snape WJ, Farrugia G, Lee L, Tonascia J, Unalp-Arida A, Hamilton F; NIDDK Gastroparesis Clinical Research Consortium. Psychological dysfunction is associated with symptom severity but not disease etiology or degree of gastric retention in patients with gastroparesis. Am J Gastroenterol. 2010 Nov;105(11):2357-67. doi: 10.1038/ajg.2010.253. Epub 2010 Jun 29. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Koch KL, Hasler WL, Van Natta M, Calles-Escandon J, Grover M, Pasricha PJ, Snape WJ, Parkman HP, Abell TL, McCallum RW, Nguyen LA, Sarosiek I, Farrugia G, Tonascia J, Lee L, Miriel L, Hamilton F; NIDDK Gastroparesis Clinical Research Consortium. Satiety testing in diabetic gastroparesis: Effects of insulin pump therapy with continuous glucose monitoring on upper gastrointestinal symptoms and gastric myoelectrical activity. Neurogastroenterol Motil. 2020 Jan;32(1):e13720. doi: 10.1111/nmo.13720. Epub 2019 Oct 1. — View Citation

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Mottalib A, Abrahamson MJ, Pober DM, Polak R, Eldib AH, Tomah S, Ashrafzadeh S, Hamdy O. Effect of diabetes-specific nutrition formulas on satiety and hunger hormones in patients with type 2 diabetes. Nutr Diabetes. 2019 Sep 24;9(1):26. doi: 10.1038/s41387-019-0093-x. — View Citation

Nguyen L, Wilson LA, Miriel L, Pasricha PJ, Kuo B, Hasler WL, McCallum RW, Sarosiek I, Koch KL, Snape WJ, Farrugia G, Grover M, Clarke J, Parkman HP, Tonascia J, Hamilton F, Abell TL; NIDDK Gastroparesis Clinical Research Consortium (GpCRC). Autonomic function in gastroparesis and chronic unexplained nausea and vomiting: Relationship with etiology, gastric emptying, and symptom severity. Neurogastroenterol Motil. 2020 Aug;32(8):e13810. doi: 10.1111/nmo.13810. Epub 2020 Feb 15. — View Citation

Orthey P, Yu D, Van Natta ML, Ramsey FV, Diaz JR, Bennett PA, Iagaru AH, Fragomeni RS, McCallum RW, Sarosiek I, Hasler WL, Farrugia G, Grover M, Koch KL, Nguyen L, Snape WJ, Abell TL, Pasricha PJ, Tonascia J, Hamilton F, Parkman HP, Maurer AH; NIH Gastroparesis Consortium. Intragastric Meal Distribution During Gastric Emptying Scintigraphy for Assessment of Fundic Accommodation: Correlation with Symptoms of Gastroparesis. J Nucl Med. 2018 Apr;59(4):691-697. doi: 10.2967/jnumed.117.197053. Epub 2017 Sep 28. — View Citation

Palsson OS, Whitehead WE, van Tilburg MA, Chang L, Chey W, Crowell MD, Keefer L, Lembo AJ, Parkman HP, Rao SS, Sperber A, Spiegel B, Tack J, Vanner S, Walker LS, Whorwell P, Yang Y. Rome IV Diagnostic Questionnaires and Tables for Investigators and Clinicians. Gastroenterology. 2016 Feb 13:S0016-5085(16)00180-3. doi: 10.1053/j.gastro.2016.02.014. Online ahead of print. — View Citation

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. — View Citation

Parkman HP, Hasler WL, Fisher RS; American Gastroenterological Association. American Gastroenterological Association technical review on the diagnosis and treatment of gastroparesis. Gastroenterology. 2004 Nov;127(5):1592-622. doi: 10.1053/j.gastro.2004.09.055. — View Citation

Parkman HP, Jones MP. Tests of gastric neuromuscular function. Gastroenterology. 2009 May;136(5):1526-43. doi: 10.1053/j.gastro.2009.02.039. Epub 2009 Mar 16. — View Citation

Parkman HP, Wilson LA, Hasler WL, McCallum RW, Sarosiek I, Koch KL, Abell TL, Schey R, Kuo B, Snape WJ, Nguyen L, Farrugia G, Grover M, Clarke J, Miriel L, Tonascia J, Hamilton F, Pasricha PJ. Abdominal Pain in Patients with Gastroparesis: Associations with Gastroparesis Symptoms, Etiology of Gastroparesis, Gastric Emptying, Somatization, and Quality of Life. Dig Dis Sci. 2019 Aug;64(8):2242-2255. doi: 10.1007/s10620-019-05522-9. Epub 2019 Mar 9. — View Citation

Parkman HP, Wilson LA, Yates KP, Koch KL, Abell TL, McCallum RW, Sarosiek I, Kuo B, Malik Z, Schey R, Shulman RJ, Grover M, Farrugia G, Miriel L, Tonascia J, Hamilton F, Pasricha PJ; NIDDK/NIH Clinical Gastroparesis Consortium. Factors that contribute to the impairment of quality of life in gastroparesis. Neurogastroenterol Motil. 2021 Aug;33(8):e14087. doi: 10.1111/nmo.14087. Epub 2021 Jan 25. — View Citation

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. — View Citation

Parkman HP, Yates K, Hasler WL, Nguyen L, Pasricha PJ, Snape WJ, Farrugia G, Koch KL, Calles J, 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. Similarities and differences between diabetic and idiopathic gastroparesis. Clin Gastroenterol Hepatol. 2011 Dec;9(12):1056-64; quiz e133-4. doi: 10.1016/j.cgh.2011.08.013. Epub 2011 Aug 24. — View Citation

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. — View Citation

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. — View Citation

Pasricha PJ, Colvin R, Yates K, Hasler WL, Abell TL, Unalp-Arida A, Nguyen L, Farrugia G, Koch KL, Parkman HP, Snape WJ, Lee L, Tonascia J, Hamilton F. Characteristics of patients with chronic unexplained nausea and vomiting and normal gastric emptying. Clin Gastroenterol Hepatol. 2011 Jul;9(7):567-76.e1-4. doi: 10.1016/j.cgh.2011.03.003. Epub 2011 Mar 11. — View Citation

Pasricha PJ, Grover M, Yates KP, Abell TL, Bernard CE, Koch KL, McCallum RW, Sarosiek I, Kuo B, Bulat R, Chen J, Shulman RJ, Lee L, Tonascia J, Miriel LA, Hamilton F, Farrugia G, Parkman HP; National Institute of Diabetes and Digestive and Kidney Diseases/National Institutes of Health Gastroparesis Clinical Research Consortium. Functional Dyspepsia and Gastroparesis in Tertiary Care are Interchangeable Syndromes With Common Clinical and Pathologic Features. Gastroenterology. 2021 May;160(6):2006-2017. doi: 10.1053/j.gastro.2021.01.230. Epub 2021 Feb 3. — View Citation

Pasricha PJ, Yates KP, Nguyen L, Clarke J, Abell TL, Farrugia G, Hasler WL, Koch KL, Snape WJ, McCallum RW, Sarosiek I, Tonascia J, Miriel LA, Lee L, Hamilton F, Parkman HP. Outcomes and Factors Associated With Reduced Symptoms in Patients With Gastroparesis. Gastroenterology. 2015 Dec;149(7):1762-1774.e4. doi: 10.1053/j.gastro.2015.08.008. Epub 2015 Aug 21. — View Citation

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Taylor F, Higgins S, Carson RT, Eremenco S, Foley C, Lacy BE, Parkman HP, Reasner DS, Shields AL, Tack J, Talley NJ; Patient-Reported Outcome Consortium's Functional Dyspepsia Working Group. Development of a Symptom-Focused Patient-Reported Outcome Measure for Functional Dyspepsia: The Functional Dyspepsia Symptom Diary (FDSD). Am J Gastroenterol. 2018 Jan;113(1):39-48. doi: 10.1038/ajg.2017.265. Epub 2017 Sep 19. — View Citation

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* Note: There are 54 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Presence or absence of Carnett's sign for abdominal wall pain at baseline.	Presence or absence Carnett's sign for abdominal wall pain at baseline. Carnett's sign is a finding on clinical examination in which (acute) abdominal pain remains unchanged or increases when the muscles of the abdominal wall are tensed. As part of the abdominal examination, the patient is asked to lift the head and shoulders from the examination table to tense the abdominal muscles. An alternative is to ask the patient to raise both legs with straight knees.; A positive test indicates the increased likelihood that the abdominal wall and not the abdominal cavity is the source of the pain (for example, due to rectus sheath hematoma instead of appendicitis). A negative Carnett's sign is said to occur when the abdominal pain decreases when the patient is asked to lift the head; this points to an intra-abdominal cause of the pain	Baseline
Primary	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.	Change in PAGI-SYM total score from baseline to 48 weeks. The final PAGI-SYM contains 20 items grouped into 6 subscales covering: heartburn/regurgitation (7 items), nausea/vomiting (3 items), post-prandial fullness/early satiety (4 items), bloating (2 items), upper abdominal pain (2 items), and lower abdominal pain (2 items). A 6-point Likert response scale, ranging from 0 (none) to 5 (very severe), is used for rating the severity of each symptom item over a 2-week recall period.; Subscale scores vary from 0 to 5; Total score varies from 0 to 5; Lower score = better health	48 weeks
Secondary	Changes in gastric emptying, as measured by gastric emptying scintigraphy (GES) at baseline and 48 weeks	Changes in gastric emptying, as measured by gastric emptying scintigraphy (GES) at baseline and 48 weeks.; Normal values for gastric emptying scintigraphy have been established in earlier studies using healthy volunteers. Gastric retention of 99mTc > 60% at 2 hours and/or > 10% at 4 hours is considered evidence of delayed gastric emptying of solids.	Baseline, 48 weeks