Clonidine HCl Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

Clonidine hydrochloride is currently evaluated across multiple clinical trials addressing acute and specialized medical contexts, including postoperative pain, emergence delirium, opiate withdrawal syndrome, and scoliosis. Spanning Phase 1 through Phase 3, these investigations are sponsored by a combination of academic institutions, hospital networks, and pharmaceutical developers, such as Assiut University and Rigshospitalet Denmark. Recorded trial recruitment statuses currently include actively recruiting, not yet recruiting, unknown status, and terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05943613	Not yet recruiting	Postoperative Pain	Assiut University	2023-12-01	Phase 1
NCT05091242	Recruiting	Emergence Delirium	Rigshospitalet Denmark	2021-10-25	Phase 2\|Phase 3
NCT05029401	Unknown status	Opiate Withdrawal Syndrome	DemeRx IB Inc.\|MAC Clinical Research\|ERT: Clinical Trial Technology Solutions\|Hammersmith Medicines Research	2021-04-01	Phase 1\|Phase 2
NCT03537612	Terminated	Scoliosis	Dr. Jean A. Ouellet MD FRCSC\|Shriners Hospitals for Children	2018-06-22	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Clonidine HCl acts as a direct-acting alpha-2 adrenergic agonist that selectively binds presynaptic alpha-2 receptors in the brainstem vasomotor center, decreasing presynaptic calcium influx and inhibiting norepinephrine release. This reduction in sympathetic tone diminishes peripheral vascular resistance and central neurotransmission, providing therapeutic modulation relevant to clinical applications such as postoperative pain control, emergence delirium, and opiate withdrawal management.

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>).