Clinical Trials

A clinical trial sponsored by an academic entity, Osaka University, evaluated Cyclic AMP sodium to investigate the relationship between vasopressin, vasopressin V2 receptors, and inner ear pathology in patients with Meniere's disease. Although no formal clinical phase was specified, the recruitment status for this research is completed. Overall, the documented clinical research landscape for Cyclic AMP sodium reflects targeted academic investigation into vasopressin receptor pathway dynamics in Meniere's disease.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00599560 COMPLETED
Meniere Disease
Osaka University
 1998-04

(data from https://clinicaltrials.gov, updated on 2016-03-29)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an adenosine triphosphate derivative and intracellular second messenger, cyclic AMP sodium binds to key downstream effector proteins such as protein kinase A, driving catalytic phosphorylation cascades that govern intracellular signal transduction and metabolic pathways. This modulation of downstream cellular signaling regulates ion transport and fluid homeostasis, establishing physiological relevance to clinical evaluations investigating inner ear dynamics in Meniere's disease.

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>).

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Note: Technical data last updated: Sep 1, 2026.