Drugs / Etodolac
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | LODINE XL | — | 1999-05-27 – 2000-08-11 | fda.gov ↗ |
| Label expansion | US (FDA) | LODINE | — | 1996-06-28 | fda.gov ↗ |
| Approved | US (FDA) | LODINE | — | 1991-01-31 | fda.gov ↗ |
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 24 trials | ||||||
| Phase 2 | NCT07308470 | Jan → Feb 2026 overdue | osteoarthritis, knee | Pharos University in Alexandria | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06839144 | Mar 2025 → Aug 2026 overdue | ovarian cancer | Tel-Aviv Sourasky Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT01857817 | Jun 2013 → Apr 2016 | prostate neoplasm | Vicus Therapeutics | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01265576 | Dec 2010 → Feb 2014 | hepatocellular carcinoma | Vicus Therapeutics | Unknown | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT01506154 | Dec 2011 → Oct 2012 | bursitis, tendinitis | MEDRx USA, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01198834 | Sep 2010 → Jun 2011 | — | MEDRx USA, Inc. | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT05679453 | Jul → Sep 2022 | — | Kutahya Health Sciences University | Completed | No outcome recorded |
| Phase 4 | NCT02881619 | Nov 2014 → Jul 2015 | — | Flavia Pardo Salata Nahsan | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT05429970 | Jun 2022 → Jun 2027 expected | fallopian tube cancer, ovarian carcinoma, primary peritoneal carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| — | NCT00502684 | Jun 2014 → Jan 2016 | female breast carcinoma | Kaplan Medical Center | Unknown | No outcome recorded |
| Comparator or background therapy9 trials | ||||||
| Phase 2 | NCT03838029 Comparator | Nov 2019 → Jan 2026 | malignant pancreatic neoplasm | Assaf-Harofeh Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT03919461 Comparator | Feb 2019 → Feb 2027 expected | colorectal neoplasm | Assaf-Harofeh Medical Center | Recruiting | No outcome recorded |
| Phase 3 | NCT03127592 Comparator | Oct 2020 → Jul 2022 | — | Apsen Farmaceutica S.A. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01118572 Comparator | Feb → Nov 2010 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00888797 Comparator | Jan 2010 → Jan 2017 | colorectal neoplasm | Sheba Medical Center | Unknown | No outcome recorded |
| — | NCT07493226 Comparator | Apr 2026 → Feb 2027 expected | frozen shoulder, neuropathy, painful | Konya Beyhekim Training and Research Hospital | Recruiting | No outcome recorded |
| — | NCT05261971 Comparator | Dec 2018 → Mar 2020 | — | Yuzuncu Yil University | Completed | No outcome recorded |
| — | NCT04626063 Comparator | Jun 2018 → Mar 2019 | — | Istanbul University | Completed | No outcome recorded |
| — | NCT01638962 Comparator | Aug 2012 → Aug 2015 | osteoarthritis, knee | University of Southern Denmark | Completed | No outcome recorded |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Etodolac | “A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the Efficacy, Tolerability and Safety of MRX-7EAT Etodolac-Lidocaine Topical Patch in...” NCT01506154 ↗18“Patients randomized into this group (n=40) will, again by simple randomization, be given oral tablets of etodolac or diclofenac” NCT07493226 ↗ “The following will be used in the study for VT-122: propranolol 22 mg immediate-release capsules and etodolac 340 mg capsules.” NCT01857817 ↗ “Group A included isolated NSAID treatment and received 400 mg etodolac twice a day.” NCT04626063 ↗ “Etodolac, 400 mg tid per a day for four days” NCT05679453 ↗ “Etodolac” NCT01638962 ↗ |
| Known as | Etopan | “Etodolac (Etopan) - patients will receive 400mg of etodolac XL twice a day starting two days before and continuing through two days after surgery.” NCT00502684 ↗ |
| Action | Inhibit | “The COX-2 inhibitor chosen is Etodlac (Etopan), which has the advantage of being a selective COX-2 inhibitor” NCT00502684 ↗ |
| Route | Oral | “Both study medications will be given orally” NCT00888797 ↗ |