Mepivacaine HCl Clinical Trials

Size	Price	Qty
50mg	USD 97
1g	USD 670

Clinical Trials

Mepivacaine hydrochloride has been evaluated across several clinical trials investigating local anesthetic effectiveness and regional pain management strategies in conditions such as hip and knee osteoarthritis, chronic renal insufficiency, and dental applications. Ranging from Phase 1 and Phase 4 to designs where phase classification is not applicable, these studies encompass completed, terminated, and not yet recruiting statuses. Sponsored by academic and healthcare institutions including the Ottawa Hospital Research Institute, Rigshospitalet, and the University of Campinas, the trials evaluate anesthetic performance, pharmacokinetic profiles, and regional regimens across distinct clinical settings.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04257682	Not yet recruiting	Knee Osteoarthritis\|Hip Osteoarthritis	Ottawa Hospital Research Institute	2022-09	Phase 4
NCT01533545	Terminated	Renal Insufficiency Chronic	Rigshospitalet Denmark	2012-09	Not Applicable
NCT01032798	Completed	Local Anesthetic Effectiveness	University of Campinas Brazil\|Fundação de Amparo à Pesquisa do Estado de São Paulo	2007-05	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Mepivacaine binds to voltage-gated sodium channels on neuronal membranes, preventing the transient influx of sodium ions and blocking downstream membrane depolarization. This inhibition halts the propagation of action potentials along peripheral sensory nerve fibers, thereby suppressing nociceptive transmission to provide regional anesthesia for clinical indications such as joint osteoarthritis procedures and dental applications.

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>).