Metoclopramide

證據等級: L5

預測適應症: 10 個

Metoclopramide: From Antiemetic/Prokinetic Use to Gastric Ulcer

One-Sentence Summary

Metoclopramide is a dopamine D2-receptor antagonist used clinically as an antiemetic and gastrointestinal prokinetic (nausea, vomiting, delayed gastric emptying) — this description is drawn from supporting literature in this evidence pack, as the drug’s registered original indication and mechanism-of-action fields are not populated in the source data. The TxGNN model predicts it may be effective for Gastric Ulcer, with 2 clinical trials and 20 publications currently associated with this direction — however, the supporting evidence is mechanistically weak and largely preclinical.

Quick Overview

Item	Content
Original Indication	Not recorded in registry data; literature in this pack describes metoclopramide as an antiemetic / GI prokinetic (nausea, vomiting, delayed gastric emptying)
Predicted New Indication	Gastric Ulcer
TxGNN Prediction Score	99.93%
Evidence Level	L4
Australia Market Status	Not marketed
Number of ARTG Entries	0
Recommended Decision	Hold

Why is This Prediction Reasonable?

Detailed mechanism-of-action data for metoclopramide is not available from DrugBank in this evidence pack (data gap DG002, severity: High). Based on literature included in this pack, metoclopramide is a dopamine D2-receptor antagonist that increases gastric emptying and lower oesophageal sphincter tone, and is used clinically as a prokinetic agent and antiemetic (including for chemotherapy-induced nausea and vomiting).

Gastric ulcer healing is driven by acid suppression, mucosal protection, and (where relevant) H. pylori eradication or removal of an offending agent such as an NSAID — none of which are mechanisms metoclopramide possesses. The evidence pack’s own mechanistic assessment states this directly: metoclopramide has “no acid-suppressive or mucosal-protective mechanism” and is “not directly related to the pathophysiology of ulcer healing.”

Some preclinical (animal) studies show a modest ulcer-protective effect, plausibly attributable to improved gastric emptying and reduced pyloric reflux rather than a direct antiulcer action, but this has not been translated into a demonstrated clinical treatment effect. The prediction should therefore be read as a plausible mechanistic hypothesis worth monitoring, not as evidence of clinical efficacy.

Clinical Trial Evidence

Trial Number	Phase	Status	Enrolment	Key Findings
NCT05746377	Phase 4	Unknown	60	Tests whether metoclopramide premedication before endoscopy for upper GI bleeds reduces the need for repeat endoscopy/IR/surgery and improves endoscopic visibility — a periprocedural aid, not a gastric ulcer treatment trial (relevance grade B).
NCT03747107	N/A	Completed	19	Primary-care prescribing safety quality-improvement study (P-DQIP); metoclopramide appears only as one of several monitored drug therapy risks, not as a gastric ulcer intervention (relevance grade C).

Literature Evidence

PMID	Year	Type	Journal	Key Findings
16807979	2006	RCT	Yonsei Med J	Double-blind RCT of IV metoclopramide vs ranitidine on preoperative gastric contents before day-case laparoscopic surgery — not a treatment-of-ulcer study.
19225	1977	Review	Drugs	Review of drug treatment options for gastric and duodenal ulcer.
6336644	1983	Review	Ann Intern Med	General pharmacology and clinical applications of metoclopramide (antiemetic, GI prokinetic); no ulcer-specific data.
775822	1976	Unclassified	ZFA	“Therapy of gastric and duodenal ulcer with Metoclopramide” — title directly on-topic; abstract not available in this pack.
2730234	1989	Animal	Arch Int Pharmacodyn Ther	Rat study: metoclopramide showed an ulcer-protective effect in aspirin-induced and pylorus-ligated gastric ulcer models, without affecting acid secretion.
6436177	1984	Animal	Indian J Physiol Pharmacol	Guinea-pig study: metoclopramide protected against experimentally induced gastric ulceration via improved gastric drainage, not acid suppression.
4779253	1973	Unclassified	Curr Med Res Opin	“Bile reflux in gastric ulcer: the effect of smoking, metoclopramide and carbenoxolone sodium” — title on-topic; abstract not available.
6106882	1980	Unclassified	Medizinische Klinik	“[Conservative treatment of gastric ulcer]” — title on-topic; abstract not available.
8095331	1993	Unclassified	Postgrad Med	Review of therapeutic strategies for peptic lesions refractory to standard H2-antagonist/sucralfate regimens; metoclopramide not central.
797497	1976	Unclassified	Clin Pharmacokinet	General discussion of drugs and diseases (including gastric ulcer) that alter gastric emptying.

Australia Market Information

Metoclopramide has 0 ARTG entries in this evidence pack — it is not currently marketed in Australia, so no product-level ARTG table is available.

Safety Considerations

Please refer to the TGA-approved Product Information (PI) for safety information.

Conclusion and Next Steps

Decision: Hold

Rationale: The mechanistic case is weak — metoclopramide has no acid-suppressive or mucosal-protective action relevant to ulcer healing — and clinical trial support is indirect (periprocedural endoscopy use, not ulcer treatment). Evidence level is L4 (preclinical/mechanistic), insufficient to progress past initial screening (decision stage S1).

To proceed, the following is needed:

TFDA/TGA product-label warnings and contraindications (data gap DG001, Blocking — currently prevents any S1 safety assessment)
Confirmed mechanism of action from DrugBank (data gap DG002, High)
A registered original indication/regulatory history for metoclopramide, since none is populated in the current evidence pack
A dedicated, ulcer-specific clinical trial (rather than periprocedural or unrelated studies) before reconsidering this indication
Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.