A Phase 3 interventional study of Metoclopramide and Placebo in Upper Gastrointestinal Bleeding, sponsored by Universidad Autonoma de Nuevo Leon. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-09.
Sponsored by Universidad Autonoma de Nuevo Leon · Phase 3, Interventional, and Diagnostic
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.
A prospective, longitudinal, randomized, double-blind study will be carried out in which all patients who come to the University Hospital "Dr. José Eleuterio González" with upper gastrointestinal tract bleeding, defined in our study as hematemesis or melena, including patients with this condition in the 24 hours prior to admission. 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. 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; 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. The diagnosis of origin of the upper gastrointestinal tract bleeding will be determined by the physician in charge of performing the endoscopy. All cases will be filmed and another physician will review the cases and validate the Avgerinos score, as well as the final diagnosis reported.
343 studies on the registry are indexed under Gastrointestinal Hemorrhage; 80 are open to participants now.
This study's enrollment of 50 is below the median of 86 across 214 interventional studies indexed under Gastrointestinal Hemorrhage.
Browse Gastrointestinal Hemorrhage studies →Universidad Autonoma de Nuevo Leon is the lead sponsor of 53 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Patients will be randomized to receive metoclopramide 20 mg IV single dose.
Drug: Metoclopramide
Patients will be randomized to receive placebo 10 ml IV single dose.
Drug: Placebo
Patients will receive metoclopramide 20 mg IV in a single dose prior to randomization.
Patients will receive placebo 10 ml IV in a single dose prior to randomization.
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.
Time frame: 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
To determine whether the use of metoclopramide avoids repeating the endoscopic procedure.
The need to repeat the endoscopic procedure will be evaluated in case clinical data of new bleeding from the digestive tract, evidenced by melena or hematemesis is found.
Time frame: 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.
The days of hospital stay will be counted and comparing both arms.
Time frame: 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.
Plan to share: No
Ran from Mar 2023 to primary completion in Jun 2024, 15 months.
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Studies of the drug tested here: Metoclopramide
Universidad Autonoma de Nuevo Leon