Multiple clinical trials evaluate mepivacaine across diverse applications and investigational phases. A Phase 4 study sponsored by the Ottawa Hospital Research Institute assesses regional anesthesia in knee or hip osteoarthritis but is not yet recruiting, whereas a terminated study without an assigned phase, led by Rigshospitalet Denmark, investigated systemic absorption during brachial plexus blocks in chronic renal insufficiency. Additionally, a completed Phase 1 trial sponsored by the University of Campinas Brazil in collaboration with the Fundação de Amparo à Pesquisa do Estado de São Paulo evaluated the efficacy and pharmacokinetics of liposomal mepivacaine formulations.
| 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)
Mechanism and Biochemical Profile
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>).