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NCT03331965 · ClinicalTrials.gov registry record · Phase 2
Metoclopramide Versus Placebo for GJ Placement
A Phase 2 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
NCT03331965 is a Phase 2 study that has completed, run by Duke University. The registered enrollment target is 110 participants.
The verdict
NCT03331965, a Phase 2 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 110 participants
- Enrollment target
Study Summary
The goal of this study is to determine whether use of promotility agents to stimulate gastric peristalsis can reduce fluoroscopy time and procedure time during gastrojejunostomy (GJ) tubes placement in interventional radiology (IR). The investigators hypothesize that increased gastric peristalsis will aid in advancing a guidewire through the pylorus, a time consuming and tedious step required during GJ tube placement. In order to maximize scientific rigor and clinical practice impact, the investigators aim to answer this question through a blinded, randomized, placebo controlled trial. Specific Aim 1: To test the hypothesis that a single dose of IV metoclopramide immediately prior to GJ tube placement reduces the fluoroscopy time required to advance a guidewire through the pylorus. Specific Aim 2: To determine whether a single dose of IV metoclopramide immediately prior to GJ tube placement reduces total procedure fluoroscopy time, air kerma and total procedure time. Specific Aim 3: To assess the safety of a single dose of promotility agent prior to GJ tube placement by assessing rates of adverse events in the periprocedural period in patients receiving IV metoclopramide versus placebo.
Interventions
- DRUG Saline
- DRUG Metoclopramide 5 MG/ML Injectable Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2018-04-09 |
| Est. Completion | 2019-10-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03331965
The ClinicalTrials.gov registry entry for NCT03331965 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Saline is the first listed.
NCT03331965 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03331965 about?
NCT03331965 is a clinical study titled "Metoclopramide Versus Placebo for GJ Placement". The goal of this study is to determine whether use of promotility agents to stimulate gastric peristalsis can reduce fluoroscopy time and procedure time during gastrojejunostomy (GJ) tubes placement in interventional radiology (IR). The investigators hypothesize that increased gastric peristalsis wi...
What is the current status of trial NCT03331965?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2018-04-09. Estimated completion is 2019-10-03.
What interventions are being tested in trial NCT03331965?
The interventions under investigation include: Saline (DRUG), Metoclopramide 5 MG/ML Injectable Solution (DRUG).
Who is sponsoring clinical trial NCT03331965?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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