Metoclopramide in Upper Gastrointestinal Bleed

NCT05746377 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: #323
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

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

Keywords

metoclopramide; prokinetic; Upper endoscopy; EGD; endoscopic gastroduodenoscopy; esophagogastroduodenoscopy

Outcome Measures

Primary Outcomes (2)

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

  Will collect if repeat procedure occurred due to poor visibility (True/False)

  During Current Hospitalization (up to day 14)

• Toronto Upper Gastroenterology Cleaning Score (TUGS)

  Standardized 0-12 point scale for describing upper gastrointestinal tract visibility, 0 indicating poor visibility, and 12 indicating excellent visibility

  During Endoscopy Procedure

Secondary Outcomes (6)

• Length of Hospital stay (days)

  During Current Hospitalization (up to day 14)

• Types of Adverse Neurological Side effects

  3 month f/u

• Glasgow-Blatchford Bleeding Score

  within 3 hours after admission

• Endoscopy Findings

  During Endoscopy Procedure

• Endoscopy Start and End Times

  During Endoscopy Procedure

Study Arms (2)

Metoclopramide

EXPERIMENTAL

Given 10 mg Metoclopramide prior to Endoscopy

Drug: Metoclopramide 10mg

Placebo

PLACEBO COMPARATOR

Given saline flush prior to Endoscopy

Drug: Saline

Interventions

Metoclopramide 10mg DRUG

IV Metoclopramide

Also known as: Reglan

Metoclopramide

Saline DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mercy Health System: lead

Study Sites (1)

Javon Bea Hospital-Riverside - MercyHealth

Rockford, Illinois, 61114, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 20970794 BACKGROUND

• 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.

  PMID: 35642290 BACKGROUND

• 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.

  PMID: 21704823 BACKGROUND

• 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.

  PMID: 33929377 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Hemorrhage; Ulcer

Interventions

Metoclopramide; Sodium Chloride

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Mudassar K Sandozi, DO

CONTACT

(815) 971-2544; msandozi@mhemail.org

Altaf Dawood, MD

CONTACT

(815) 971-2544; adawood@mhemail.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Randomization protocol instituted by pharmacy, patient and endoscopist blinded to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 27, 2023
• Study Start: May 20, 2023
• Primary Completion: February 1, 2024
• Study Completion: June 1, 2024
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)