What side effects are associated with this type of intervention?

Metoclopramide, used to enhance gastrointestinal motility and accelerate gastric emptying in the treatment of Upper Gastrointestinal Bleeding, is associated with several side effects. Common side effects include drowsiness, fatigue, and restlessness. More serious side effects can involve extrapyramidal symptoms such as tardive dyskinesia, which are involuntary, repetitive body movements. Other rare but severe side effects may include neuroleptic malignant syndrome and depression.

What prior FDA approvals exist?

The FDA has approved several treatments for Upper Gastrointestinal Bleeding (UGIB), focusing primarily on medications that enhance gastrointestinal motility and accelerate gastric emptying. Metoclopramide, a prokinetic agent, is one such drug that has been studied for its potential to improve the effectiveness of endoscopic interventions in UGIB by enhancing visibility and reducing the need for repeat procedures. Other related drugs include erythromycin, which is used off-label to promote gastric emptying in acute settings. These treatments aim to manage symptoms and improve clinical outcomes in patients with UGIB.

What other types of research exist?

Promising novel alternatives to Metoclopramide for UGIB patients include prokinetic agents like Prucalopride, which is a 5-HT4 receptor agonist that enhances colonic motility. Additionally, newer formulations of erythromycin, a macrolide antibiotic with prokinetic properties, are being explored for their efficacy in improving gastric emptying. These alternatives are being considered due to their potential to offer similar or improved outcomes in gastrointestinal motility and gastric emptying.

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Dopamine Antagonist

Metoclopramide for Upper Gastrointestinal Bleeding

Phase 4

Recruiting

Research Sponsored by Mercy Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 month f/u

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing if metoclopramide can help doctors see better during an endoscopy for patients with upper GI bleeds. By making the stomach and intestines move more, metoclopramide may clear out blood, reducing the need for repeat procedures and improving treatment.

Who is the study for?

This trial is for adults over 18 with upper GI bleeding, who are set to have an endoscopy within 24 hours of hospital admission or symptom onset at Javon Bea Hospital MercyHealth Riverside. They must have a Glasgow-Blatchford score ≥ 2. Excluded are those allergic to metoclopramide, with certain tumors, Parkinson's, epilepsy, pregnant or breastfeeding women, previous gastrectomy patients, and those on drugs causing movement disorders.

What is being tested?

The study tests if metoclopramide can reduce the need for additional interventions like repeat endoscopies or surgeries in upper GI bleed cases and if it improves visibility during an endoscopic exam. Participants will receive either Metoclopramide 10mg or saline as a control.

What are the potential side effects?

Metoclopramide may cause side effects such as tiredness, restlessness, depression and poor concentration. It might also lead to serious movement disorders (tardive dyskinesia) especially when used long-term.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 month f/u

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 month f/u

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 month f/u for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Need for repeat endoscopy, Interventional Radiology Intervention or Surgery due to poor visibility

Toronto Upper Gastroenterology Cleaning Score (TUGS)

Secondary study objectives

Endoscopy Findings

Endoscopy Start and End Times

Glasgow-Blatchford Bleeding Score

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MetoclopramideExperimental Treatment1 Intervention

Given 10 mg Metoclopramide prior to Endoscopy

Group II: PlaceboPlacebo Group1 Intervention

Given saline flush prior to Endoscopy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metoclopramide 10mg

2019

Completed Phase 4

~550

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Metoclopramide, a common treatment for Upper Gastrointestinal Bleeding (UGIB), works by enhancing gastrointestinal motility and accelerating gastric emptying. This mechanism is crucial for UGIB patients as it helps clear the stomach contents, improving visibility during endoscopic procedures and potentially reducing the need for repeat interventions. Additionally, by promoting gastric emptying, metoclopramide can decrease the risk of further bleeding and improve patient outcomes. Other common treatments for UGIB include proton pump inhibitors (PPIs) that reduce gastric acid secretion, and endoscopic therapies that directly address the bleeding source.

Effects of Metoclopramide on Esophageal Motor Activity and Esophagogastric Junction Compliance in Healthy Volunteers.