Nitrofurantoin Clinical Trials

Size	Price	Qty
100mg	USD 147

Clinical Trials

Multiple clinical trials evaluate the clinical utility and prophylactic application of nitrofurantoin across indications including urinary tract infections, pelvic organ prolapse, postoperative pain associated with irreversible pulpitis, and clinical quality audit initiatives. Supported by pharmaceutical sponsors such as GlaxoSmithKline and academic entities like the University of Pittsburgh, these Phase 3, Phase 4, and non-applicable phase protocols encompass actively recruiting, completed, and terminated recruitment statuses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05630833	Recruiting	Urinary Tract Infections	GlaxoSmithKline	2023-01-11	Phase 3
NCT05817253	Completed	Clinical Audit\|Quality Improvement	University of British Columbia\|Ministry of Health British Columbia	2021-09-23	Not Applicable
NCT04900571	Completed	Pain Postoperative\|Irreversible Pulpitis	Altamash Institute of Dental Medicine	2021-01-01	Phase 4
NCT02727322	Completed	Pelvic Organ Prolapse	Halina M Zyczynski MD\|University of Pittsburgh	2016-08	Phase 4
NCT00678041	Terminated	Urinary Tract Infections	University of Pittsburgh	2008-05	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nitrofurantoin is reduced by bacterial flavoproteins into reactive intermediates that directly inhibit bacterial DNA, RNA, cell wall, and protein synthesis. This multifaceted suppression of essential cellular macromolecules results in bacterial cell death, providing therapeutic efficacy against urinary tract infections.

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>).