Doxepin HCl Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

A clinical trial evaluating doxepin hydrochloride was conducted as a completed Phase 3 study sponsored by the Alliance for Clinical Trials in Oncology in collaboration with the National Cancer Institute. The investigation assessed the therapeutic efficacy of a doxepin oral rinse compared to placebo for mitigating acute pain caused by radiation-induced oral mucositis and associated oral complications in patients receiving radiotherapy for head and neck cancer. Overall, clinical evaluation of this compound focuses on supportive care interventions for radiation therapy complications in oncology populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01156142	Completed	Head and Neck Cancer\|Mucositis\|Oral Complications of Radiation Therapy\|Pain	Alliance for Clinical Trials in Oncology\|National Cancer Institute (NCI)	2010-12	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Doxepin hydrochloride functions as a potent histamine receptor antagonist, blocking downstream histamine-mediated biochemical signaling and monoamine transport to suppress inflammatory cascades and nociceptive neuronal firing. This targeted inhibition of histamine receptors and sensory signaling dampens local pain pathways, offering clinical utility in relieving acute oral mucositis pain in patients undergoing radiation therapy for head and neck cancer.

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>).