Indigo carmine Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Multiple clinical trials evaluate indigo carmine as a chromoendoscopic contrast agent for diagnostic gastrointestinal procedures in conditions such as Lynch syndrome, inflammatory bowel diseases, colonic polyps, and ulcerative colitis. Encompassing Phase 1, non-interventional, and unclassified trial phases, these investigations are sponsored by academic medical centers and research foundations, including the Mayo Clinic, Assistance Publique - Hôpitaux de Paris, the ARC Foundation for Cancer Research, and Hillel Yaffe Medical Center. Overall recruitment is predominantly completed, with certain studies remaining under an unknown status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02570516	Completed	Lynch Syndrome	Assistance Publique - Hôpitaux de Paris\|ARC Foundation for Cancer Research	2015-11	Not Applicable
NCT01914445	Unknown status	Inflammatory Bowel Diseases	Hillel Yaffe Medical Center	2013-08	Not Applicable
NCT01901510	Completed	Colonic Polyps	Mayo Clinic	2013-05	Phase 1
NCT00961948	Completed	Ulcerative Colitis	Mayo Clinic	2009-06	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a non-absorbed pH indicator dye, indigo carmine pools within gastrointestinal mucosal crevices without penetrating epithelial cells. This contrast distribution delineates surface microarchitecture and tissue topography, facilitating the endoscopic identification and clinical evaluation of colonic polyps, ulcerative colitis, inflammatory bowel diseases, and lesions in Lynch syndrome.

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>).