Metoclopramide in Upper Gastrointestinal Bleed

NCT ID: NCT05746377

Last Updated: 2023-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-20

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this clinical trial is to test if metoclopramide can improve effectiveness of endoscopic intervention in upper gastrointestinal (GI) bleeds. The main questions the investigators hope to answer is

Does metoclopramide lessen the need for repeat endoscopy, interventional radiology intervention or surgery in cases of upper GI bleed?

Does metoclopramide improve visibility of the GI walls in cases of upper GI bleed?

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of the study is to see if giving metoclopramide prior to an endoscopy in cases of upper GI bleed can decrease the need for repeat endoscopy due to poor visibility. Metoclopramide stimulates stomach and intestine activity. It is used to treat nausea, vomiting and slow gut movement. The investigators are testing if metoclopramide's effect on stimulating stomach activity can lead to more effective emptying of blood from the stomach and upper intestines in upper GI bleeding so physicians conducting endoscopies can easily see the stomach and intestinal wall and treat the source of bleeding.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Upper GI Bleeding Bleeds Gastric Bleed Ulcer Hemorrhage Gastric Hemorrhage; Ulcer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
Randomization protocol instituted by pharmacy, patient and endoscopist blinded to treatment assignment.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Metoclopramide

Given 10 mg Metoclopramide prior to Endoscopy

Group Type EXPERIMENTAL

Metoclopramide 10mg

Intervention Type DRUG

IV Metoclopramide

Placebo

Given saline flush prior to Endoscopy

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Metoclopramide 10mg

IV Metoclopramide

Intervention Type DRUG

Saline

Placebo

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Reglan

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 18 and above
* Admitted to ER or inpatient services at Javon Bea Hospital MercyHealth Riverside
* Present with upper GI bleeding defined as fresh and bright red hematemesis, coffee-ground hematemesis or melena
* Plan to undergo EGD within 24 hours since admission or since first symptoms
* Calculated Glasgow-Blatchford score ≥ 2

Exclusion Criteria

* Failure to obtain informed consent
* Known allergy to metoclopramide
* Concurrent use of medications known to cause tardive dyskinesia (TD)/extrapyramidal symptoms/neuroleptic malignant syndrome
* History of TD or dystonic reaction to metoclopramide
* Pheochromocytoma, catecholamine-releasing paragangliomas
* Parkinson's Disease
* Epilepsy
* Pregnancy or lactation
* Previous gastrectomy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mercy Health System

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mudassar Sandozi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Javon Bea Hospital-Riverside - MercyHealth

Rockford, Illinois, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mudassar K Sandozi, DO

Role: CONTACT

(815) 971-2544

Altaf Dawood, MD

Role: CONTACT

(815) 971-2544

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Altaf Dawood

Role: primary

815-971-7000

References

Explore related publications, articles, or registry entries linked to this study.

Barkun AN, Bardou M, Martel M, Gralnek IM, Sung JJ. Prokinetics in acute upper GI bleeding: a meta-analysis. Gastrointest Endosc. 2010 Dec;72(6):1138-45. doi: 10.1016/j.gie.2010.08.011.

Reference Type BACKGROUND
PMID: 20970794 (View on PubMed)

Khan R, Gimpaya N, Vargas JI, Ramkissoon A, Seleq S, Gholami R, Akhtar HJ, Bansal R, Scaffidi MA, Amin S, Bollipo S, Kral J, Lui R, Pawlak KM, Sandhu DS, Bilal M, de-Madaria E, Siau K, Charabaty A, Hashim A, Sanchez-Luna SA, Teshima CW, May GR, Mosko JD, Walsh CM, Grover SC. The Toronto Upper Gastrointestinal Cleaning Score: a prospective validation study. Endoscopy. 2023 Feb;55(2):121-128. doi: 10.1055/a-1865-4180. Epub 2022 May 31.

Reference Type BACKGROUND
PMID: 35642290 (View on PubMed)

Daram SR, Garretson R. Erythromycin is preferable to metoclopramide as a prokinetic in acute upper GI bleeding. Gastrointest Endosc. 2011 Jul;74(1):234; author reply 234-5. doi: 10.1016/j.gie.2011.01.059. No abstract available.

Reference Type BACKGROUND
PMID: 21704823 (View on PubMed)

Laine L, Barkun AN, Saltzman JR, Martel M, Leontiadis GI. ACG Clinical Guideline: Upper Gastrointestinal and Ulcer Bleeding. Am J Gastroenterol. 2021 May 1;116(5):899-917. doi: 10.14309/ajg.0000000000001245.

Reference Type BACKGROUND
PMID: 33929377 (View on PubMed)

Metoclopramide for Acute Upper GI Bleeding - Tabular View - ClinicalTrials.Gov. https://clinicaltrials.gov/ct2/show/record/NCT04771481. Accessed 7 Feb. 2023.

Reference Type BACKGROUND

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

#323

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Montefiore Metoclopramide Study
NCT00475306 COMPLETED PHASE4
Domperidone for Chronic Nausea and Vomiting
NCT02757534 NO_LONGER_AVAILABLE