Clinical Trials
Several clinical trials evaluate interventions for conditions including stage I–IV and recurrent uterine corpus carcinoma, Lynch syndrome, midshaft clavicle fractures, major depressive and anxiety disorders, and chronic pain. Sponsored by academic, foundation, and governmental organizations, these non-interventional or early feasibility studies have reported phases categorized as unassigned or not applicable. Active enrollment is currently absent across the studies, with recruitment statuses designated as either not yet recruiting or suspended.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT01199250 | Not yet recruiting | Lynch Syndrome|Recurrent Uterine Corpus Carcinoma|Stage I Uterine Corpus Cancer|Stage II Uterine Corpus Cancer|Stage III Uterine Corpus Cancer|Stage IV Uterine Corpus Cancer |
Gynecologic Oncology Group|National Cancer Institute (NCI)|GOG Foundation |
2100-01 | -- |
| NCT05454306 | Suspended | Clavicle Fracture |
University of Minnesota |
2028-01-09 | Not Applicable |
| NCT05118594 | Not yet recruiting | Major Depressive Disorder|Dysthymic Disorder|Specific Phobia|Social Anxiety Disorder|Panic Disorder|Agoraphobia|Generalized Anxiety Disorder |
National Council of Scientific and Technical Research Argentina |
2026-02 | Not Applicable |
| NCT06077526 | Not yet recruiting | Chronic Pain |
Bridgewater College |
2026-01-13 | Not Applicable |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Compliance for Clinical Use
Mechanism and Biochemical Profile
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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