GastroparesisGpR4NCT05846802
Gastroparesis Registry 4
An observational study of Gastroparesis and Gastroparesis Nondiabetic, run by Johns Hopkins Bloomberg School of Public Health at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gastroparesis, Gastroparesis Nondiabetic, Gastroparesis Due to Diabetes Mellitus Type I
- How many people
- 250 participants
- Where
- 6 sitesUnited States
- Study dates
- 20 Sep 2024to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults over age 18, located in the United States, with symptoms of gastroparesis and/or functional dyspepsia.
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Emily Mitchell, MS, MBA contact
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Helen B Murray, PhD, 617-726-8470, hbmurray@mgh.harvard.edu
Madison Paylor, (410)916-9307, mpaylor@mgh.harvard.edu
- Recruiting
Wake Forest University and Atrium Health Carolinas Medical Center
Charlotte, North Carolina, 28202
Baha Moshiree, MD, 704-355-4593
Kelsey Cuzzupe, 704-355-4593, Kelsey.Cuzzupe@advocatehealth.org
- Recruiting
Texas Tech University Health Science Center (TTUHSC)
El Paso, Texas, 79905
Irene Sarosiek, MD, 915-545-6626 ext. 230, irene.sarosiek@ttuhsc.edu
Denise Vasquez, (915) 214-4388, denise.vasquez@ttuhsc.edu
- Recruiting
University of Louisville
Louisville, Kentucky, 40202
Thomas Abell, MD, 502-852-7963, thomas.abell@louisville.edu
Bridget Cannon, (502) 540-1428, Bridget.cannon@louisville.edu
- Recruiting
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Henry Parkman, MD, 215-707-7579, henry.parkman@temple.edu
Rona T Cooper, 2157075477, rona.taylor@temple.edu
- Recruiting
Jay Pasricha
Scottsdale, Arizona, 85259
Jay Pasricha, MD, pasricha.jay@mayo.org
Guillermo Barahona, Barahona.Guillermo@mayo.edu
About this study
Official title: Gastroparesis Registry 4 (GpR4): Improving the Understanding of Gastroparesis and Functional Dyspepsia
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.
Read the detailed 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.
- Conditions
- 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
- Medical subject headings
- Gastroparesis, Gastrointestinal Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gastroparesis | Gastroparesis symptoms with delayed emptying | |
| Functional Dyspepsia | Gastroparesis symptoms without delayed emptying |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 weeks
Secondary outcomes (1)
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.
Measured: Baseline, 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start20 Sep 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (54)Papers the sponsor has linked to this study.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Tech University Health Sciences Center, El Paso, Temple University, University of Louisville, Mayo Clinic, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Massachusetts General Hospital, Wake Forest University
- Responsible party
- Sponsor
- Investigators
- Jay Pasricha, MD, Principal investigator, Mayo ClinicHenry Parkman, MD, Principal investigator, Temple UniversityDavid Shade, JD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846802
- Sponsor's protocol ID
- 14-DK-GpR4
- Other IDs
- U01DK073975, U01DK074035, U01DK074007, U24DK074008, U01DK073983, U01DK112193, U01DK073974, IRB00401119
- Acronym
- GpR4
- Status last verified
- Mar 2026
- First submitted
- 25 Apr 2023
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Public use complete database will be submitted to the NIDDK Data Repository
Publications
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.
PubMed 15521026Camilleri M, Parkman HP, Shafi MA, Abell TL, Gerson L; American College of Gastroenterology. Clinical guideline: management of gastroparesis. Am J Gastroenterol. 2013 Jan;108(1):18-37; quiz 38. doi: 10.1038/ajg.2012.373. Epub 2012 Nov 13.
PubMed 23147521Stanghellini V, Chan FK, Hasler WL, Malagelada JR, Suzuki H, Tack J, Talley NJ. Gastroduodenal Disorders. Gastroenterology. 2016 May;150(6):1380-92. doi: 10.1053/j.gastro.2016.02.011.
PubMed 27147122Schol J, Wauters L, Dickman R, Drug V, Mulak A, Serra J, Enck P, Tack J; ESNM Gastroparesis Consensus Group. United European Gastroenterology (UEG) and European Society for Neurogastroenterology and Motility (ESNM) consensus on gastroparesis. Neurogastroenterol Motil. 2021 Aug;33(8):e14237. doi: 10.1111/nmo.14237.
PubMed 34399024Pasricha 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.
PubMed 33548234Pasricha 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.
PubMed 21397732Makarov OV, Khashchukoeva AZ, Borisenko SA, Epeikina TN, Moiseeva NB. [Immunologic aspects of ovarian tumors]. Akush Ginekol (Mosk). 1988 Nov;(11):3-6. No abstract available. Russian.
PubMed 3071162Vijayvargiya P, Jameie-Oskooei S, Camilleri M, Chedid V, Erwin PJ, Murad MH. Association between delayed gastric emptying and upper gastrointestinal symptoms: a systematic review and meta-analysis. Gut. 2019 May;68(5):804-813. doi: 10.1136/gutjnl-2018-316405. Epub 2018 Jun 2.
PubMed 29860241Lacy BE, Crowell MD, Cangemi DJ, Lunsford TN, Simren M, Tack J. Diagnostic Evaluation of Gastric Motor and Sensory Disorders. Am J Gastroenterol. 2021 Dec 1;116(12):2345-2356. doi: 10.14309/ajg.0000000000001562.
PubMed 35134012Revicki DA, Camilleri M, Kuo B, Norton NJ, Murray L, Palsgrove A, Parkman HP. Development and content validity of a gastroparesis cardinal symptom index daily diary. Aliment Pharmacol Ther. 2009 Sep 15;30(6):670-80. doi: 10.1111/j.1365-2036.2009.04078.x. Epub 2009 Jun 25.
PubMed 19558608Yu D, Ramsey FV, Norton WF, Norton N, Schneck S, Gaetano T, Parkman HP. The Burdens, Concerns, and Quality of Life of Patients with Gastroparesis. Dig Dis Sci. 2017 Apr;62(4):879-893. doi: 10.1007/s10620-017-4456-7. Epub 2017 Jan 21.
PubMed 28110376Parkman 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.
PubMed 33493377Hasler 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.
PubMed 23414452Hasler 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.
PubMed 30326297Parkman 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.
PubMed 30852767
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastroparesis Registry 4 (GpR4): Improving the Understanding of Gastroparesis and Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT05846802
- Acronym / sponsor ID
- GpR4 / 14-DK-GpR4
- Conditions
- 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 type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Texas Tech University Health Sciences Center, El Paso, Temple University, University of Louisville, Mayo Clinic, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Massachusetts General Hospital, Wake Forest University
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastroparesis | – | –Gastroparesis symptoms with delayed emptying |
| Functional Dyspepsia | – | –Gastroparesis symptoms without delayed emptying |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults over age 18, located in the United States, with symptoms of gastroparesis and/or functional dyspepsia.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 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
1 secondary outcome
Changes in gastric emptying, as measured by gastric emptying scintigraphy (GES) at baseline and 48 weeks
Time frame: Baseline, 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Background: PubMed 15521026Parkman 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.
- Background: PubMed 23147521Camilleri M, Parkman HP, Shafi MA, Abell TL, Gerson L; American College of Gastroenterology. Clinical guideline: management of gastroparesis. Am J Gastroenterol. 2013 Jan;108(1):18-37; quiz 38. doi: 10.1038/ajg.2012.373. Epub 2012 Nov 13.
- Background: PubMed 27147122Stanghellini V, Chan FK, Hasler WL, Malagelada JR, Suzuki H, Tack J, Talley NJ. Gastroduodenal Disorders. Gastroenterology. 2016 May;150(6):1380-92. doi: 10.1053/j.gastro.2016.02.011.
- Background: PubMed 34399024Schol J, Wauters L, Dickman R, Drug V, Mulak A, Serra J, Enck P, Tack J; ESNM Gastroparesis Consensus Group. United European Gastroenterology (UEG) and European Society for Neurogastroenterology and Motility (ESNM) consensus on gastroparesis. Neurogastroenterol Motil. 2021 Aug;33(8):e14237. doi: 10.1111/nmo.14237.
- Background: PubMed 33548234Pasricha 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.
- Background: PubMed 21397732Pasricha 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.
- Background: PubMed 3071162Makarov OV, Khashchukoeva AZ, Borisenko SA, Epeikina TN, Moiseeva NB. [Immunologic aspects of ovarian tumors]. Akush Ginekol (Mosk). 1988 Nov;(11):3-6. No abstract available. Russian.
- Background: PubMed 29860241Vijayvargiya P, Jameie-Oskooei S, Camilleri M, Chedid V, Erwin PJ, Murad MH. Association between delayed gastric emptying and upper gastrointestinal symptoms: a systematic review and meta-analysis. Gut. 2019 May;68(5):804-813. doi: 10.1136/gutjnl-2018-316405. Epub 2018 Jun 2.
- Background: PubMed 35134012Lacy BE, Crowell MD, Cangemi DJ, Lunsford TN, Simren M, Tack J. Diagnostic Evaluation of Gastric Motor and Sensory Disorders. Am J Gastroenterol. 2021 Dec 1;116(12):2345-2356. doi: 10.14309/ajg.0000000000001562.
- Background: PubMed 19558608Revicki DA, Camilleri M, Kuo B, Norton NJ, Murray L, Palsgrove A, Parkman HP. Development and content validity of a gastroparesis cardinal symptom index daily diary. Aliment Pharmacol Ther. 2009 Sep 15;30(6):670-80. doi: 10.1111/j.1365-2036.2009.04078.x. Epub 2009 Jun 25.
- Background: PubMed 28110376Yu D, Ramsey FV, Norton WF, Norton N, Schneck S, Gaetano T, Parkman HP. The Burdens, Concerns, and Quality of Life of Patients with Gastroparesis. Dig Dis Sci. 2017 Apr;62(4):879-893. doi: 10.1007/s10620-017-4456-7. Epub 2017 Jan 21.
- Background: PubMed 33493377Parkman 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.
- Individual participant dataSharing planned: Yes. Public use complete database will be submitted to the NIDDK Data Repository
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily Mitchell, MS, MBA contact
Jay Pasricha, MD principal investigator
Mayo Clinic
Henry Parkman, MD principal investigator
Temple University
David Shade, JD principal investigator
Johns Hopkins Bloomberg School of Public Health
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroparesis and Gastroparesis Nondiabetic, run by Johns Hopkins Bloomberg School of Public Health at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Miriel (4435024165, lmiriel1@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05846802, which also lists 54 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.