Usefulness of Metoclopramide to Improve Endoscopic Visualization in Upper Gastrointestinal Bleeding

NCT06297954 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: GA22-00011
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, randomized, double-blind study will be conducted, including all patients with upper gastrointestinal bleeding, defined as vomiting blood or black bowel movements, within 24 hours prior to admission. Patients will be randomized to receive intravenous metoclopramide 20 mg or placebo, a placebo is a look-alike substance that contains no active drug. Then endoscopy will be performed in the following 120 minutes, evaluating endoscopic visualization with the modified Avgerinos scale.

Conditions

Upper Gastrointestinal Bleeding

Keywords

Metoclopramide; Endoscopy; Hematemesis; Melena

Outcome Measures

Primary Outcomes (1)

• To determine the usefulness of metoclopramide in improving endoscopic visualisation in patients with upper gastrointestinal bleeding.

  Using modified Avgerinos scale; which gives a score of 0-2 according to the percentage of mucosal vision; 0 = \<25% visible surface, 1 = 25%-75% visible surface and 2= \>75% visible surface, evaluating fundus, body, antrum and bulb, a score ≥ 6 will be considered a clean stomach and a score ≤ 5 will be considered full stomach.

  From admission to discharge for up to 5 days, during this time their clinical condition will be evaluated, through a general physical examination, taking vital signs and questioning them about possible side effects associated with metoclopramide

Secondary Outcomes (2)

• To determine whether the use of metoclopramide avoids repeating the endoscopic procedure.

  From admission to discharge for up to 5 days, during this time it will be evaluated the need for new endoscopy in case clinical data of new bleeding from the digestive tract evidenced by melena or hematemesis.

• To determine whether the use of metoclopramide shortens the length of hospital stay.

  From admission to discharge for up to 30 days, during this time their clinical condition will be evaluated, through a general physical examination, taking vital signs and questioning them about possible side effects associated with metoclopramide.

Study Arms (2)

Metoclopramide

EXPERIMENTAL

Patients will be randomized to receive metoclopramide 20 mg IV single dose.

Drug: Metoclopramide

Placebo

PLACEBO COMPARATOR

Patients will be randomized to receive placebo 10 ml IV single dose.

Drug: Placebo

Interventions

Metoclopramide DRUG

Patients will receive metoclopramide 20 mg IV in a single dose prior to randomization.

Metoclopramide

Placebo DRUG

Patients will receive placebo 10 ml IV in a single dose prior to randomization.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized patients ≥18 years of age with variceal and non-variceal upper gastrointestinal tract bleeding (hematemesis and/or melena).
• ≤12 hours of bleeding evolution.
• Hemodynamic stability at the time of upper endoscopy.

You may not qualify if:

• Patients \<18 years old.
• Pregnant patients.
• Metoclopramide allergy.
• Refusal to be part of the study protocol.

Sponsors & Collaborators

• Universidad Autonoma de Nuevo Leon: lead

Study Sites (1)

Hospital Universitario Dr. José Eleuterio González, UANL

Monterrey, Nuevo León, 64460, Mexico

Location

Related Publications (1)

• Estes DJ, Berera S, Deshpande AR, Sussman DA. Re-Visiting Metoclopramide to Optimize Visualization with Gastrointestinal Bleeding - Mobilizing Existing Data. Clin Endosc. 2019 Sep;52(5):516-517. doi: 10.5946/ce.2019.046. Epub 2019 Jul 16. No abstract available.

  PMID: 31309766 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Hematemesis; Melena

Interventions

Metoclopramide

Condition Hierarchy (Ancestors)

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

Study Officials

• José Luis Herrera Elizondo, Physician

  Hospital Universitario Dr. José Eleuterio González, UANL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: As it is double-blind, both physician and patient will not know the treatment they are receiving and it will only be revealed later at the end of the protocol. Following the previous folios, both the treatment and the placebo will be distributed in boxes by default by the research staff, delivering them to the personnel who will apply the drug or placebo, indicating the doses and frequencies of these when administered.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients will be randomized to receive metoclopramide 20 mg IV or placebo, this randomization will be performed by means of a computer sequence to receive each of the treatment sequences. The sequence of treatment (metoclopramide) and placebo in which they will be distributed to patients will be determined using randomization software. A folio number will be assigned and depending on the sequence the treatment or placebo will be administered. Subsequently, the upper endoscopy will be performed in the following 120 minutes, and the endoscopic visualization will be evaluated by the physician performing the procedure by means of the modified Avgerinos scale

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 7, 2024
• Study Start: March 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)