Sucralfate
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Sucralfate: From Duodenal Ulcer to Duodenogastric Reflux
One-Sentence Summary
Sucralfate is a non-systemic mucosal protectant, originally used to treat duodenal ulcer. The TxGNN model predicts it may be effective for duodenogastric reflux (score 99.4%), but no clinical trials or publications were retrieved for this specific indication, so the prediction rests on model output and mechanistic plausibility alone. The closest evidence-backed directions are esophagitis / peptic esophagitis (1 small early-phase trial, about 20 publications) and related upper gastrointestinal conditions.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Duodenal ulcer |
| Predicted New Indication | Duodenogastric reflux |
| TxGNN Prediction Score | 99.37% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 1 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the data compiled for this report. Based on the supplied literature, sucralfate is a basic aluminium salt of sulphated sucrose. It is minimally absorbed and acts locally. It adheres to damaged or ulcerated mucosa, forming a protective barrier against acid, pepsin and bile salts. Reviews also describe stimulation of mucus, bicarbonate and prostaglandin production.
Duodenogastric reflux is the backflow of duodenal contents, including bile, into the stomach. Because sucralfate adsorbs bile salts and protects the mucosa, a benefit is biologically plausible. Duodenal ulcer, the original indication, and duodenogastric reflux both involve mucosal injury in the upper gastrointestinal tract. However, the data compiled for this report contain no trial or publication that directly supports this link.
Several other predictions have stronger support, and the main ones are summarised below for context:
| Predicted Indication | TxGNN Score | Evidence Level | Comment |
|---|---|---|---|
| Esophagitis | 97.5% | L3 | One completed early Phase 1 study (n=3) of sucralfate slurry |
| Peptic esophagitis | 95.9% | L3 | Older randomised comparisons (for example versus alginate/antacid or ranitidine) and reviews; acid suppression is now standard of care |
| Duodenitis | 95.4% | L4 | Indirect evidence from general sucralfate and ulcer reviews |
| Active peptic ulcer disease | 95.3% | L4 | Mechanistic and older reviews; no trials supplied |
| Gastroduodenitis | 94.3% | L4 | Mechanism reviews and veterinary or NSAID papers |
| Gastrojejunal ulcer | 94.0% | L4 | Indirect evidence only |
| Peptic ulcer perforation | 94.0% | L4 | Mucosal protectant is not a treatment for an acute surgical emergency; value would lie in prevention only |
| Duodenal obstruction | 99.3% | L5 | Likely a knowledge-graph artefact; obstruction is mechanical |
| C1 inhibitor deficiency | 94.2% | L5 | No plausible mechanism; likely a graph artefact |
Clinical Trial Evidence
Currently no related clinical trials registered for duodenogastric reflux.
For reference, the trials found for the nearest predicted indication (esophagitis) are:
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT02353078 | Early Phase 1 | Completed | 3 | Sucralfate slurry in eosinophilic esophagitis; measured dilated intercellular spaces, tight junctions and mucosal impedance. No efficacy conclusions. |
| NCT02039869 | N/A | Withdrawn | 0 | Confocal endomicroscopy in non-erosive reflux disease; no efficacy data and not a sucralfate study. |
Literature Evidence
Currently no related literature available for duodenogastric reflux.
For reference, selected publications for the nearest indication (peptic esophagitis) are:
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 2986275 | 1985 | Randomised double-blind comparison | Scand J Gastroenterol | Sucralfate vs alginate/antacid over 6 weeks (68 completers); about 70% improved or symptom-free, and esophagitis healed in 53% of the sucralfate group |
| 2821808 | 1987 | Randomised double-blind comparison | Am J Med | Sucralfate vs alginate/antacid in 50 patients; no significant difference in efficacy |
| 3310628 | 1987 | Randomised controlled study | Am J Med | Sucralfate vs ranitidine in 49 patients with reflux esophagitis over 8 weeks |
| 1561531 | 1992 | Randomised double-blind | Scand J Gastroenterol | Sucralfate plus ranitidine vs sucralfate alone in 75 patients |
| 2660561 | 1989 | Randomised double-blind | Am J Med | Sucralfate plus cimetidine vs sucralfate alone in 70 patients, with maintenance phase |
| 3917956 | 1985 | Preclinical (rabbit) | Gastroenterology | Sucralfate prevented experimental peptic esophagitis |
| 6372664 | 1984 | Review | Annu Rev Med | Alkaline (bile) reflux gastritis and esophagitis; the pathology most relevant to duodenogastric reflux |
| 1882898 | 1991 | Review | Am J Med | Overview of sucralfate therapy in reflux esophagitis |
| 2190304 | 1990 | Review (mechanism) | Scand J Gastroenterol Suppl | Adsorption of pepsin and bile acids, stimulation of bicarbonate and mucus secretion |
| 1611711 | 1992 | Review | Dig Dis | Sucralfate binds bile acids and pepsin and adheres to mucosa |
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN08585P | APO-SUCRALFATE TABLET 1 g (Apotex Inc) | Tablet (oral) | Not stated in the data compiled for this report |
Safety Considerations
- Contraindication signals from the knowledge graph (not package insert text): hyperglycaemia, chronic kidney disease, chronic renal failure syndrome and end-stage renal failure. Sucralfate contains aluminium, so use in renal impairment warrants particular attention.
- Drug interactions (100 interactions recorded; examples from the 20 retrieved):
- Major: dolutegravir, bictegravir
- Moderate: doxycycline, tetracycline, alendronic acid, risedronic acid, ibandronate, acarbose, alogliptin, pioglitazone, albiglutide, allopurinol, ascorbic acid, calcifediol, baloxavir marboxil
- Minor: acebutolol, atenolol, betaxolol, bisoprolol, anagrelide
Many of these likely reflect binding or reduced absorption, so dose separation may be needed.
Please refer to the package insert for warnings and contraindications from the label.
Conclusion and Next Steps
Decision: Hold
Rationale: The duodenogastric reflux prediction is supported only by the model score (L5), with no trials or publications. The mechanism is plausible, but that is not evidence. Esophagitis and peptic esophagitis have more support, but it is old, small or indirect, and acid suppression is now standard of care.
To proceed, the following is needed:
- A targeted search for sucralfate in bile or alkaline reflux (gastritis or esophagitis), including post-gastrectomy settings
- A decision on whether to pursue peptic esophagitis, which has the strongest supporting literature, as the lead direction and to assess its design quality
- The Singapore package insert, to obtain approved indications, warnings and contraindications
- Mechanism of action data from DrugBank
- A renal safety and aluminium exposure assessment, and a dose-separation plan for the interacting drugs, particularly dolutegravir and bictegravir
- Confirmation of oral route and formulation suitability, which is currently pending
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.