Pantoprazole Clinical Trials

Size	Price	Qty
100mg	USD 97
500mg	USD 297

Clinical Trials

Pantoprazole is evaluated across multiple clinical trials spanning Phase I, Phase III, and Phase IV studies targeting gastrointestinal and metabolic conditions, including gastroesophageal reflux disease, non-erosive reflux disease, pediatric obesity, and non-alcoholic fatty liver disease. These investigations, which include pharmacokinetic evaluations in pediatric populations, encompass various statuses ranging from actively recruiting and completed to terminated, withdrawn, or unknown. Research is sponsored by academic medical institutions such as Children's Mercy Hospital Kansas City and Duke University, as well as pharmaceutical companies including Pfizer, Ahn-Gook Pharmaceuticals, and Eurofarma Laboratorios.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04248335	Recruiting	Pediatric Obesity\|NAFLD\|GERD	Children''s Mercy Hospital Kansas City	2018-07-03	Phase 4
NCT02401035	Terminated	Gastroesophageal Reflux Disease	Pfizer	2017-05-09	Phase 4
NCT02274961	Unknown status	Non Erosive Reflux Disease	Ahn-Gook Pharmaceuticals Co.Ltd	2014-10	Phase 3
NCT02186652	Completed	Gastroesophageal Reflux Disease	Phillip Brian Smith\|The Emmes Company LLC\|Duke University	2014-06-04	Phase 1
NCT01710462	Withdrawn	Gastroesophageal Reflux Disease	Eurofarma Laboratorios S.A.	2013-08	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pantoprazole irreversibly binds to the gastric parietal cell (H+/K+)-ATPase enzyme system, blocking the final step of hydrogen ion secretion into the gastric lumen and suppressing acid production. This potent reduction in gastric acid secretion alleviates mucosal irritation and facilitates tissue healing in acid-mediated pathologies such as gastroesophageal reflux disease and non-erosive 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>).