Esomeprazole magnesium Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Several clinical trials evaluate esomeprazole magnesium across Phase 1 through Phase 4 studies and observational protocols. These investigations encompass gastrointestinal conditions—including reflux esophagitis and gastroesophageal reflux disease with sleep disturbances—as well as gastric acid suppression, advanced malignancies, and healthy volunteers. Sponsored by pharmaceutical companies and academic medical institutions, recruitment statuses across these studies range from completed and unknown to early termination.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02477475	Completed	Reflux Esophagitis	AstraZeneca	2015-07-07	--
NCT02277886	Unknown status	Gastroesophageal Reflux Disease\|Heartburn\|Sleep Disturbance	Chang Gung Memorial Hospital\|TTY Biopharm	2014-11	Phase 4
NCT01130935	Completed	Gastric Acid Suppression\|Proton Pump Inhibitors	AstraZeneca	2010-05	--
NCT01135472	Completed	Healthy	City of Hope Medical Center	2010-03	Phase 1
NCT00332748	Terminated	Cancer	Bristol-Myers Squibb	2006-12	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Esomeprazole magnesium acts as a proton pump inhibitor that selectively binds to and inhibits the H+/K+-ATPase enzyme in gastric parietal cells, thereby blocking the terminal step of gastric acid production. By suppressing hydrogen ion secretion into the gastric lumen, this cellular inhibition reduces overall gastric acidity to provide therapeutic relief in conditions such as reflux esophagitis and gastroesophageal reflux disease.

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>).