Drugs / valdecoxib
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Bextra | — | 2008-03-27 | europa.eu ↗ |
| Label expansion | US (FDA) | BEXTRA | — | 2004-04-23 | fda.gov ↗ |
| Approved | EU (EMA) | Bextra | — | 2003-03-27 | europa.eu ↗ |
| Approved | US (FDA) | BEXTRA | — | 2001-11-16 | fda.gov ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT00115752 | Jun 2005 → Oct 2006 | — | National Institute of Nursing Research (NINR) | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT00651300 | Apr 2003 → Mar 2004 | — | Pfizer | Terminated | No outcome recorded |
| Phase 3 | NCT00092339 | Aug → Sep 2002 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00092300 | May → Sep 2002 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT00260325 | Aug 2004 → Apr 2006 | — | Penn State University | Completed | No outcome recorded |
| Phase 4 | NCT00660855 | Jun → Jul 2004 | — | Pfizer | Terminated | No outcome recorded |
| Phase 4 | NCT00122096 | Nov 2002 → Jan 2006 | — | University of Washington | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00021996 | Jan 2001 → Feb 2004 | cancer of unknown primary site | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Comparator or background therapy20 trials | ||||||
| Phase 2 | NCT00602901 Background | Jul 2004 → Oct 2006 | chronic pain syndrome, subacute bursitis | Palmer College of Chiropractic | Completed | No outcome recorded |
| Phase 2 | NCT00650624 Comparator | Jun 2003 → Jan 2004 | osteoarthritis, knee | Pfizer | Completed | No outcome recorded |
| Phase 2/3 | NCT00419549 Comparator | Oct 2003 → Sep 2005 | acute pancreatitis | All India Institute of Medical Sciences | Terminated | No outcome recorded |
| Phase 3 | NCT00652808 Comparator | May → Sep 2004 | osteoarthritis, knee | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00650039 Comparator | Mar 2004 → Feb 2005 | — | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00648258 Comparator | Jul 2003 → Apr 2004 | osteoarthritis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00647829 Comparator | Feb → Dec 2003 | pharyngitis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00636064 Comparator | Jan 2003 → Jan 2004 | — | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00653354 Comparator | Dec 2002 → Mar 2003 | — | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00661635 Comparator | Nov 2002 → Jul 2003 | gallbladder disorder | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00683137 Comparator | Oct 2002 → Feb 2003 | toe, misshapen | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00650598 Comparator | Mar → Aug 2004 | neuropathy, painful | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT01361789 Comparator | Jan 2004 → Dec 2009 | — | Asker & Baerum Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00657449 Comparator | Jun 2003 → Oct 2004 | — | Pfizer | Terminated | No outcome recorded |
| Phase 4 | NCT00650455 Comparator | Feb 2003 → Jan 2005 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00649415 Comparator | Jan → Jul 2003 | primary dysmenorrhea | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00671320 Comparator | Dec 2002 → Oct 2003 | — | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00649610 Comparator | Nov 2002 → May 2003 | — | Pfizer | Completed | No outcome recorded |
| — | NCT01541137 Comparator | Mar 2004 → Sep 2008 | — | Helsinki University Central Hospital | Completed | No outcome recorded |
| — | NCT00763997 Comparator | Feb → Dec 2004 | platelet aggregation, spontaneous | Ruhr University of Bochum | Completed | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 29 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | valdecoxib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00649415 ↗ |
| Known as | Bextra | “40 mg parecoxib (Dynastat, Pfizer®) one hour before surgery and 40 mg valdecoxib (prodrug of parecoxib, Bextra, Pfizer®)were given 8 hour after surgery.” NCT01361789 ↗2“Bextra® (Valdecoxib) 20 Mg Twice Daily, Bextra® 40 Mg Once Daily, And Placebo” NCT00647829 ↗ “Bextra: po, 10mg, qd, six weeks” NCT00602901 ↗ |
| Known as | NSC-759846 | ChEMBL registry synonym — accepted as the source's own label CHEMBL865 ↗ |
| Known as | SC-65872 | “Clinical Protocol for a Randomized Double-Blind, Placebo-Controlled Comparison of the Analgesic Activity of Valdecoxib (SC-65872) 40mg BID as Add-On Therapy to Opioid...” NCT00021996 ↗ |
| Known as | Valdyn | ChEMBL registry synonym — accepted as the source's own label CHEMBL865 ↗ |
| Known as | Valdyn (previously kudeq) | ChEMBL registry synonym — accepted as the source's own label CHEMBL865 ↗ |
| Action | Inhibit | “COX inhibitor” NCT00115752 ↗ |
| Modality | Small molecule | — CHEMBL865 ↗ |
| Route | Oral | “Patients receive oral valdecoxib twice daily” NCT00021996 ↗ |
| Target | PTGS2 | “selective COX-2 inhibitor” NCT00419549 ↗ |