Lappaconitine Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

A clinical trial evaluates the efficacy and safety of a topical adhesive patch containing lappaconitine for managing oral mucositis pain resulting from chemoradiotherapy in patients with head and neck malignancies, such as nasopharyngeal carcinoma. Sponsored by Fujian Cancer Hospital, the study leverages the drug's analgesic properties to mitigate treatment-induced mucosal toxicity. The trial's phase is classified as Not Applicable, and its recruitment status is currently recorded as unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03518489	Unknown status	Radiation Induced Oral Mucositis	Fujian Cancer Hospital	2018-07-01	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lappaconitine acts as a human sodium channel blocker that inhibits voltage-gated sodium currents, thereby preventing neuronal membrane depolarization and action potential propagation. This suppression of nociceptive signaling in sensory nerves reduces pain perception, supporting its clinical development for managing radiation-induced oral mucositis pain in patients undergoing chemoradiotherapy.

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>).