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NCT03876288 · ClinicalTrials.gov registry record
Gastroparesis Outcome Longitudinal Database Enrolled Numerically
A clinical trial of Gastroparesis, sponsored by University of Louisville.
- Recruiting
- Registry status
- 3,000
- Enrollment target
- 1
- Study location
NCT03876288: Recruiting study of Gastroparesis, sponsored by University of Louisville.
NCT03876288 is a study of Gastroparesis that is actively recruiting participants, run by University of Louisville. The registered enrollment target is 3,000 participants, above the 234-participant average among 44 other Gastroparesis trials with a reported enrollment target (1182% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03876288, a study of Gastroparesis, is actively recruiting participants, sponsored by University of Louisville.
- RECRUITING
- Registry status
- 3,000 participants
- Enrollment target
- 1
- Study location
Study Summary
GOLDEN is a longitudinal database of patients with the symptoms (Sx) of gastroparesis (Gp) who were seen and recorded at the University of Louisville from 2012 and is ongoing. Patients are enrolled and followed by sequential numbers and may include legacy patients seen at other centers by some of the same team and who are reported as part of the series. Outcome relate to patients Sx, survival, quality of life and other measures as detailed below, over time. The study tracks patients regardless of treatment but specifically focuses on GI Neuromodulation (gastric electrical stimulation - GES), Immunotherapy (IVIG), and Pyloric therapies (pyloroplasty, endoscopic). If treatments were administered GOLDEN allows for examination and stratification of outcome by groups both at baseline and at follow up.
Primary Outcome
The primary outcome measures are patient symptoms via the traditional gastroparesis patient reported outcome scale. It uses a 0-4 scale from none to worse on GI Symptoms; for example: Nausea,Vomiting, Anorexia/Early Satiety, Bloating/distension, Abdominal Pain. Scored as each item plus a total that is the sum of the individual scales.The five Sx subscales of 0-4 each are summed for a total score range 0-20
Conditions Studied
Interventions
- DRUG Immunotherapy
- DEVICE GI Neuromodulation
- PROCEDURE Pyloric Therapies
Study Locations (1)
Kentucky
- University of Louisville - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,000 participants |
| Start Date | 2013-01-01 |
| Est. Completion | 2028-01-01 |
What NCT03876288 shows while recruiting
NCT03876288 is an observational study that tracks outcomes without assigning an intervention. Its 3,000 participants enrollment target places it among the larger protocols in the corpus, above the 234-participant average among 44 other Gastroparesis trials with a reported enrollment target (1182% higher).
The record links to 1 condition, with Gastroparesis appearing as the primary indexed condition, and to 3 interventions - of which Immunotherapy is the first listed.
NCT03876288 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT03876288 about?
NCT03876288 is a clinical study titled "Gastroparesis Outcome Longitudinal Database Enrolled Numerically". GOLDEN is a longitudinal database of patients with the symptoms (Sx) of gastroparesis (Gp) who were seen and recorded at the University of Louisville from 2012 and is ongoing. Patients are enrolled and followed by sequential numbers and may include legacy patients seen at other centers by some of th...
What is the current status of trial NCT03876288?
This trial is currently recruiting. The enrollment target is 3,000 participants. The study started on 2013-01-01. Estimated completion is 2028-01-01.
What conditions does trial NCT03876288 study?
This clinical trial studies the following conditions: Gastroparesis.
What interventions are being tested in trial NCT03876288?
The interventions under investigation include: Immunotherapy (DRUG), GI Neuromodulation (DEVICE), Pyloric Therapies (PROCEDURE).
Who is sponsoring clinical trial NCT03876288?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03876288 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03876288's enrollment target sits among peer trials
3,000 2nd of 44 the highest of 44 other Gastroparesis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastroparesis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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