Clinical Trials

Multiple completed clinical trials have evaluated trometamol-containing formulations in healthy subjects and patients with irreversible pulpitis across Phase 1 and Phase 4 studies. In a Phase 4 trial sponsored by Daniel Chavarría Bolaños and the Universidad Autónoma de San Luis Potosí, researchers evaluated the therapeutic efficacy of dexketoprofen trometamol for post-procedural pain management in endodontic patients. Additionally, a Phase 1 trial sponsored by Egalet Ltd assessed the pharmacokinetics of an intranasal ketorolac tromethamine formulation in healthy volunteers.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02086097 Completed
Irreversible Pulpitis
Daniel Chavarría Bolaños|Universidad Autonoma de San Luis Potosí
 2013-08 Phase 4
NCT01365611 Completed
Healthy Subjects
Egalet Ltd
 2007-02 Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Trometamol acts as an organic proton acceptor that binds excess hydrogen ions in extracellular fluids, effectively decreasing systemic free proton concentrations. This buffering action neutralizes metabolic acid build-up to restore physiological pH, providing direct therapeutic value in treating acidemia and facilitating stable salt combinations evaluated in clinical trials for conditions such as irreversible pulpitis.

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.