Chloroprocaine HCl Clinical Trials

Size	Price	Qty
5mg	USD 197

Clinical Trials

Several clinical trials evaluate Chloroprocaine HCl across Phase 3 and Phase 4 studies for clinical applications including general anesthesia, spinal anesthesia, cervical cerclage, and post-cesarean section pain and complications. Sponsored by academic and medical institutions such as Johns Hopkins University, Duke University, the University of Arkansas, University Hospital Ghent, and Jinling Hospital, these protocols comprise completed studies alongside a withdrawn study.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03260972	Withdrawn	Cesarean Section Complications\|Pain	Johns Hopkins University	2021-06	Phase 3
NCT03805438	Completed	Cerclage Cervical	Duke University\|University of Arkansas	2019-02-07	Phase 4
NCT03805503	Completed	Spinal Anesthesia	University Hospital Ghent	2015-09-16	Phase 4
NCT02287870	Completed	Anesthesia	Jinling Hospital China	2008-01	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Chloroprocaine HCl reversibly binds to voltage-gated sodium channels on neuronal cell membranes, inhibiting intracellular sodium influx and preventing the depolarization required for action potential generation and propagation. This inhibition blocks nerve impulse transmission along peripheral fibers, providing localized sensory blockade and analgesia relevant to surgical conditions such as spinal anesthesia, cervical cerclage, and cesarean section delivery.

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>).