Clinical Trials

Multiple clinical trials are evaluating sucralfate for clinical applications including radiation proctopathy and direct visualization of drug behavior during capsule endoscopy. Sponsored by health organizations and clinical institutions—specifically Changhai Hospital and the Manchester University NHS Foundation Trust in collaboration with the National Institute for Health Research United Kingdom—these studies range in status from active recruitment to completed. The assigned phase designations for these trials are reported as Not Applicable or unassigned.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04918758 Recruiting
Radiation Proctopathy
Manchester University NHS Foundation Trust|National Institute for Health Research United Kingdom
 2021-07-22 Not Applicable
NCT04327869 Completed
Capsule Endoscopy
Changhai Hospital
 2018-11-03 --

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Sucralfate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sucralfate binds selectively to positively charged proteins at ulcerated mucosal sites to form an insoluble protective cross-linked barrier that inhibits peptic hydrolysis and prevents enzymatic degradation of mucus. This localized cytoprotection shielding the gastrointestinal lining from gastric acid and pepsin provides therapeutic utility for mucosal injury conditions, including radiation proctopathy.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Jump to

Note: Technical data last updated: Sep 1, 2026.