Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:24 AM
Study NCT ID:
NCT05846802
Status:
RECRUITING
Last Update Posted:
2025-07-11
First Post:
2023-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gastroparesis Registry 4
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Study Overview
Official Title:
Gastroparesis Registry 4 (GpR4): Improving the Understanding of Gastroparesis and Functional Dyspepsia
Status:
RECRUITING
Status Verified Date:
2025-07
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:
GpR4
Brief 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.
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.
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 Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U01DK073975 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01DK074035 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01DK074007 | NIH | None | https://reporter.nih.gov/quic… | View |
| U24DK074008 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01DK073983 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01DK112193 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01DK073974 | NIH | None | https://reporter.nih.gov/quic… | View |
| IRB00401119 | OTHER | JHM IRB | View |