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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

Study Summary

This trial tests if a drug could improve endoscopic treatment of upper GI bleeds. Does it reduce need for repeat procedures & improve visibility?

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Toronto Upper Gastroenterology Cleaning Score (TUGS)

Secondary outcome measures

Endoscopy Findings

Endoscopy Start and End Times

Glasgow-Blatchford Bleeding Score

+3 more

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

~680

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mercy Health SystemLead Sponsor

6 Previous Clinical Trials

2,145 Total Patients Enrolled

Media Library

Metoclopramide (Dopamine Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05746377 — Phase 4

Upper Gastrointestinal Bleeding Research Study Groups: Metoclopramide, Placebo

Upper Gastrointestinal Bleeding Clinical Trial 2023: Metoclopramide Highlights & Side Effects. Trial Name: NCT05746377 — Phase 4

Metoclopramide (Dopamine Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05746377 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently any vacancies in this experimental protocol?

"Yes, the information available on clinicaltrials.gov affirms that this research is actively recruiting participants. This medical trial was initially posted on 20th May of 2021 and updated for the final time on 9th July 2021. A total of 60 people are required to participate at one location."

Answered by AI

What are the primary goals of this experimental research endeavor?

"The key purpose of this experiment, evaluated during endoscopic procedures, is to quantify the requirement for additional radiological interventions or surgery resulting from inadequate visibility. Secondary objectives encompass measuring neurological adverse reactions (i.e., dystonia, akathisia, parkinsonism and tardive dyskinesia) as well as quantifying risk of gastrointestinal bleeding using Glasgow-Blatchford Bleeding Score (0 indicating no danger while 29 signals high mortality probability). Additionally, number of blood units transfused in 24 hours will be tracked."

Answered by AI

What potential harm could be caused by Metoclopramide usage?

"Metoclopramide has been approved, thus it receives a safety score of 3."

Answered by AI

To what extent is this research being conducted with the involvement of human subjects?

"Indeed, the data available on clinicaltrials.gov proves that this medical trial is presently enrolling participants. This research project was first posted to the website on May 20th of 2023 and most recently updated on July 9th of 2023. It requires 60 patients from one site alone."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Metoclopramide in Upper Gastrointestinal Bleed

Mudassar Sandozi 2023. "Metoclopramide in Upper Gastrointestinal Bleed". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05746377.