Omeprazole
| Evidence Level: L3 | Predicted Indications: 2 |
Table of Contents
Omeprazole: From Peptic Ulcer Disease/GERD to Duodenogastric Reflux
One-Sentence Summary
Omeprazole is a proton pump inhibitor (PPI) globally established for gastroesophageal reflux disease (GERD), peptic ulcer disease, and H. pylori eradication regimens. The TxGNN model predicts it may be effective for Duodenogastric Reflux, with 1 clinical trial (low direct relevance) and 20 publications currently supporting this direction, most of which are observational, cohort, or animal studies rather than dedicated treatment trials.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not present in the local regulatory dataset (drug is not marketed); internationally approved for GERD, peptic ulcer disease, and H. pylori eradication |
| Predicted New Indication | Duodenogastric Reflux |
| TxGNN Prediction Score | 99.64% |
| Evidence Level | L3 |
| India Market Status | ✗ Not Marketed |
| Number of Registrations | 0 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the evidence pack. Based on known pharmacology, Omeprazole is a proton pump inhibitor that irreversibly inhibits the H+/K+-ATPase enzyme system in gastric parietal cells, suppressing gastric acid secretion.
Duodenogastric reflux involves backflow of duodenal contents (bile and pancreatic juice) into the stomach — these are largely non-acidic components. Omeprazole cannot directly block bile or pancreatic reflux, but by reducing gastric acid it lowers the acidic fraction of the mixed refluxate. This is why omeprazole has already been used clinically in Barrett’s esophagus patients to reduce combined acid/bile reflux exposure, even though it does not treat the underlying cause of duodenogastric reflux.
The mechanistic link is therefore partial and indirect: plausible for the acid component of the reflux picture, but not a direct treatment for the bile/pancreatic component. Notably, several animal studies in the evidence base (e.g., PMID 10389684, 33027361) suggest that acid suppression under conditions of duodenogastric reflux may actually promote gastric carcinogenesis in rat models — a caution signal that tempers the reasonableness of this prediction rather than reinforcing it.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT02685150 | N/A | Completed | 157 | Evaluated endoscopic tri-modal imaging (NBI+AFI+WLI) to distinguish functional dyspepsia from reflux disease. This is a diagnostic-tool validation study, not a treatment trial of omeprazole in duodenogastric reflux — graded low relevance (C) |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 9824338 | 1998 | Crossover Clinical Study | Gut | Omeprazole 20mg BID reduced duodenogastric and duodenogastro-oesophageal bile reflux in Barrett’s esophagus patients |
| 10994616 | 2000 | Cohort/Clinical Study | Scand J Gastroenterol | Long-term omeprazole therapy reduced antral duodenogastric reflux in Barrett’s esophagus |
| 9841990 | 1998 | Clinical Study | J Gastrointest Surg | Medical acid suppression and fundoplication both studied for bile reflux in benign/malignant Barrett’s esophagus |
| 10389684 | 1999 | Animal Study | Dig Dis Sci | Gastric acid blockade with omeprazole promoted gastric carcinogenesis in rats with induced duodenogastric reflux — safety signal |
| 33027361 | 2020 | Animal Study | Acta Cir Bras | Investigated omeprazole’s protective/harmful effect on gastric adenocarcinoma development in rats with duodenogastric reflux |
| 21916229 | 2011 | Cohort | Eksp Klin Gastroenterol | Characterized duodenogastric reflux dynamics in duodenal ulcer patients after H. pylori eradication |
| 12836018 | 2003 | Cohort | Eur J Pediatr | Described primary duodenogastric reflux presentation in children/adolescents, unresponsive to classical antacid therapy |
| 8076761 | 1994 | Observational | Gastroenterology | Related duodenogastroesophageal reflux and pH patterns to Barrett’s esophagus development |
| 11232672 | 2001 | Observational | Am J Gastroenterol | Compared acid/bile reflux burden in Barrett’s esophagus vs reflux esophagitis and effect of PPI therapy |
| 19491829 | 2009 | Clinical Study | Am J Gastroenterol | Compared degree of duodenogastroesophageal and acid reflux between once-daily PPI responders and non-responders |
India Market Information
Omeprazole currently shows 0 registrations and a “Not Marketed” status in the reviewed regulatory dataset — no license records are available to summarize.
Safety Considerations
- Drug Interactions: 673 documented interactions on file. Notable Major-level interactions include Acalabrutinib and Atazanavir (omeprazole’s acid suppression can reduce absorption/efficacy of pH-dependent drugs). Numerous Moderate-level interactions are also recorded, including Atorvastatin, Hydrochlorothiazide, Alprazolam, Amphotericin B (all formulations), Fenofibrate, Apalutamide, Armodafinil, Amikacin, and Anagrelide.
Key warnings and contraindications are not available in this dataset — please refer to the package insert for full prescribing safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: Evidence for duodenogastric reflux specifically is limited to one low-relevance diagnostic imaging trial and largely observational/animal literature (L3), and the mechanistic link is only partial (omeprazole addresses acid, not bile/pancreatic reflux). More importantly, multiple animal studies raise a genuine safety signal that acid suppression may promote gastric carcinogenesis under chronic duodenogastric reflux exposure — this is a caution flag, not just an evidence gap. A Blocking data gap (missing local package-insert warnings/contraindications) also prevents entry into S1 safety review.
To proceed, the following is needed:
- TFDA/local package insert (warnings, contraindications) to close the Blocking data gap (DG001)
- DrugBank-confirmed mechanism of action detail (DG002)
- Clarification of local licensing/original indication status, given the drug currently shows “Not Marketed”
- A dedicated interventional trial evaluating omeprazole specifically for duodenogastric reflux outcomes (current data is indirect, largely from Barrett’s esophagus cohorts)
- Follow-up on the gastric carcinogenesis signal seen in animal DGR models before advancing this candidate
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.