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NCT04208828 · ClinicalTrials.gov registry record
IVIG for Drug and Device Refractory Gastrointestinal Auto-Immune Neuropathy
A clinical trial of Gastroparesis and Neuropathy, sponsored by University of Louisville.
- Recruiting
- Registry status
- 400
- Enrollment target
- 1
- Study location
NCT04208828: Recruiting study of Gastroparesis and Neuropathy, sponsored by University of Louisville.
NCT04208828 is a study of Gastroparesis and Neuropathy that is actively recruiting participants, run by University of Louisville. The registered enrollment target is 400 participants, above the 293-participant average among 44 other Gastroparesis trials with a reported enrollment target (37% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04208828, a study of Gastroparesis and Neuropathy, is actively recruiting participants, sponsored by University of Louisville.
- RECRUITING
- Registry status
- 400 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients with the symptoms of generalized GI dysmotility, including gastroparesis, are sometimes refractory to available medications, devices and other interventions/ Some of these patients have serologic and/or endo organ abnormalities and findings consistent with autoimmune neuropathies, primarily involving the GI tract. These disorders have been known as autoimmune gastrointestinal neuropathies (GAIN) or also as autoimmune gastrointestinal dysmotility (AGID), among other terms. Some patients respond to intravenous immunoglobulin (IVIG) and this study, which is an observational clinical series, documents the patients, their findings and standardized responses to therapy with IVIG.
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
Study Locations (1)
Kentucky
- University of Louisville - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2020-01-02 |
| Est. Completion | 2028-01-02 |
What NCT04208828 shows while recruiting
NCT04208828 is an observational study that tracks outcomes without assigning an intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, above the 293-participant average among 44 other Gastroparesis trials with a reported enrollment target (37% higher).
The record links to 3 conditions, with Gastroparesis appearing as the primary indexed condition, and to 0 interventions.
NCT04208828 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT04208828 about?
NCT04208828 is a clinical study titled "IVIG for Drug and Device Refractory Gastrointestinal Auto-Immune Neuropathy". Patients with the symptoms of generalized GI dysmotility, including gastroparesis, are sometimes refractory to available medications, devices and other interventions/ Some of these patients have serologic and/or endo organ abnormalities and findings consistent with autoimmune neuropathies, primarily...
What is the current status of trial NCT04208828?
This trial is currently recruiting. The enrollment target is 400 participants. The study started on 2020-01-02. Estimated completion is 2028-01-02.
What conditions does trial NCT04208828 study?
This clinical trial studies the following conditions: Gastroparesis, Neuropathy, Gastrointestinal Motility Disorder.
Who is sponsoring clinical trial NCT04208828?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04208828 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 NCT04208828's enrollment target sits among peer trials
400 5th of 44 higher than 40 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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