Drugs / PN400
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | VIMOVO | — | 2010-04-30 | fda.gov ↗ |
Trials 3 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT00907400 | May → Sep 2009 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00761501 | Sep → Dec 2008 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT01544114 | Apr 2012 → Feb 2015 | juvenile idiopathic arthritis | Amgen | Completed | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT02604446 Background | Sep 2015 → Feb 2019 | arthritic joint disease | St. Olavs Hospital | Completed | No outcome recorded |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PN400 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00907400 ↗ |
| Known as | VIMOVO | “premedication of Dexamethasone, Paracetamol, Vimovo; postoperative Paracetamol and Vimovo” NCT02604446 ↗ |
| Route | Oral | “oral tablet” NCT00907400 ↗ |