Omeprazole
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Omeprazole: Duodenal obstruction
One-Sentence Summary
Omeprazole is a proton pump inhibitor originally used for acid-related upper gastrointestinal conditions such as gastric ulcer, duodenal ulcer, gastroesophageal reflux disease and Zollinger-Ellison syndrome.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Duodenal obstruction |
| TxGNN Prediction Score | 0.9964 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| Recommended Decision | Hold (research question only) |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Based on known information, omeprazole is a proton pump inhibitor that suppresses gastric acid secretion. Its efficacy in acid-related conditions such as reflux disease, esophagitis and peptic ulcer is well established, and it may therefore relieve the acid-related mucosal injury and symptoms that accompany bile reflux.
The link is indirect. Omeprazole does not stop bile or duodenal contents from refluxing into the stomach. Small human studies in Barrett’s oesophagus (PMIDs 10994616, 9824338) and a pediatric prospective study of oesophageal bile reflux (PMID 16641575) looked at its effect on bile reflux, and they are the main clinical-level evidence. Three rat studies (PMIDs 33027361, 10389684, 8943968) suggest that acid suppression combined with duodenogastric reflux may promote mucosal growth and gastric carcinogenesis. This is a safety signal that must be resolved before any repurposing.
A second predicted indication, duodenal obstruction (TxGNN score 0.9964), was also reviewed. It is a mechanical condition that acid suppression does not reverse. The high score probably reflects network proximity to duodenal ulcer rather than a true mechanistic link, and the evidence is limited to case reports and narrative articles. It is not recommended for further work (Hold).
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT02685150 | Not applicable | Completed | 157 | Endoscopic tri-modal imaging to tell functional dyspepsia from reflux disease. A diagnostic study that does not test omeprazole, so it gives no efficacy evidence |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 10994616 | 2000 | Small human clinical study | Scand J Gastroenterol | Effect of omeprazole on antral duodenogastric reflux in Barrett’s oesophagus |
| 9824338 | 1998 | Small human clinical study | Gut | Omeprazole 20 mg twice daily and its effect on duodenogastric and gastro-oesophageal bile reflux in Barrett’s oesophagus |
| 16641575 | 2006 | Prospective study (pediatric) | J Pediatr Gastroenterol Nutr | Proton pump inhibitor therapy for oesophageal bile reflux in children |
| 18679668 | 2008 | Review | Eur J Clin Pharmacol | Update on clinical use and pharmacokinetics of proton pump inhibitors |
| 12836018 | 2003 | Observational (pediatric) | Eur J Pediatr | Primary duodenogastric reflux in six children and adolescents with excessive bile exposure |
| 8076761 | 1994 | Clinical physiology study | Gastroenterology | Relationship of pH to duodenogastroesophageal reflux and its importance in Barrett’s oesophagus |
| 33027361 | 2020 | Animal study (rat) | Acta Cir Bras | Omeprazole and gastric adenocarcinoma in rats with duodenogastric reflux; asks whether it is protective |
| 10389684 | 1999 | Animal study (rat) | Dig Dis Sci | Gastric acid blockade with omeprazole promoted gastric carcinogenesis induced by duodenogastric reflux |
| 8943968 | 1996 | Animal study (rat) | Dig Dis Sci | Duodenogastric reflux stimulated foregut mucosal growth, which acid blockade increased |
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 163263 | Omeron 20mg Capsule | Strip of 10 capsules | Not stated |
| 35738 | Cid 20mg Capsule | Strip of 10 capsules | Not stated |
| 170302 | Ozl 20mg Capsule | Strip of 10 capsules | Not stated |
| 167146 | Omerip 20mg Capsule | Strip of 10 capsules | Not stated |
| 149654 | Momez 40mg Capsule | Strip of 10 capsules | Not stated |
There are 20 valid single-ingredient registrations in total; all are oral capsules.
Safety Considerations
- Knowledge-graph contraindication signals (not label text): liver failure, liver disease, gallbladder disease, congestive heart failure, osteoporosis, postmenopausal osteoporosis, bone fracture and chronic atrophic gastritis.
- Drug Interactions: 673 interactions are recorded. Examples of Major interactions are acalabrutinib and atazanavir. Examples of Moderate interactions are alprazolam, atorvastatin, fenofibrate, hydrochlorothiazide, amphotericin B products and apalutamide.
- Carcinogenesis concern: rat studies suggest that acid suppression combined with duodenogastric reflux may promote gastric carcinogenesis.
Please refer to the package insert for warnings and contraindications; this label information was not available when the report was compiled.
Conclusion and Next Steps
Decision: Hold
Rationale: The human evidence is limited to small studies in Barrett’s oesophagus and children, and animal data raise a carcinogenesis concern. Omeprazole does not directly block bile reflux, so this is best treated as a research question rather than a repurposing candidate.
To proceed, the following is needed:
- Package insert warnings and contraindications from the Indian regulator, which are currently missing and block safety screening
- Detailed mechanism of action data (for example from DrugBank)
- A controlled clinical study of omeprazole specifically for duodenogastric reflux
- A long-term safety assessment of the gastric carcinogenesis signal in reflux settings
- Confirmation of approved indications for the Indian licences
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.