Orphenadrine Citrate Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

A clinical trial sponsored by Mansoura University, an academic institution, evaluated the efficacy and safety of Orphenadrine Citrate against baclofen therapy for severe muscle cramps in patients with hepatic cirrhosis. Classified with a phase status of Not Applicable, the protocol ultimately ended with a terminated recruitment status prior to study completion. Consequently, clinical trial data regarding Orphenadrine Citrate for cirrhosis-associated neuromuscular symptoms remains extremely restricted.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04509336	Terminated	Cirrhosis	Mansoura University	2020-08-20	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Orphenadrine Citrate functions as a centrally acting antagonist of muscarinic acetylcholine receptors and N-methyl-D-aspartate receptors, thereby inhibiting central cholinergic and glutamatergic signaling to reduce elevated skeletal muscle tone. By suppressing hyperactive motor pathways and suppressing involuntary spasticity, this mechanism provides the therapeutic rationale for evaluating its efficacy in controlling painful muscle cramps associated with liver cirrhosis.

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>).