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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: Completed Phase 2 study, sponsored by Duke University.
NCT03331965 is a Phase 2 study that has completed, run by Duke University. The registered enrollment target is 110 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The fluoroscopy time required to advance a guidewire through the pylorus.
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 |
What the finished NCT03331965 record still lists
NCT03331965 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 2 interventions - of which Saline is the first listed.
NCT03331965 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03331965's enrollment target sits among peer trials
110 632nd of 2000 higher than 1,361 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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