drugset / Trial / NCT00665431
Efficacy Study of PN400 (VIMOVO) Twice Daily and Celebrex Once Daily in Patients With Osteoarthritis
RandomizedParallel-groupDouble-blindTreatment
Summary
We will evaluate the efficacy of PN 400 and an active comparator in patients that have Osteoarthritis of the knee.
Timeline
- Start
- 2008-04
- Primary completion
- 2008-12
- Completion
- 2009-01
Publications
- Holt RJ, Fort JG, Grahn AY, Kent JD, Bello AE. Onset and durability of pain relief in knee osteoarthritis: Pooled results from two placebo trials of naproxen/esomeprazole combination and celecoxib. Phys Sportsmed. 2015 Jul;43(3):200-12. doi: 10.1080/00913847.2015.1074852. Epub 2015 Aug 3.
- Holt RJ, Fort JG, Grahn AY, Kent JD, Bello AE. Onset and durability of pain relief in knee osteoarthritis: pooled results from two placebo trials of naproxen/esomeprazole combination and celecoxib. Phys Sportsmed. 2015 Aug 3:1-13. Online ahead of print.
- Hochberg MC, Fort JG, Svensson O, Hwang C, Sostek M. Fixed-dose combination of enteric-coated naproxen and immediate-release esomeprazole has comparable efficacy to celecoxib for knee osteoarthritis: two randomized trials. Curr Med Res Opin. 2011 Jun;27(6):1243-53. doi: 10.1185/03007995.2011.580340. Epub 2011 Apr 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Celecoxib | Other / unclassified | 200 mg | — |
| Subject | Esomeprazole | Small molecule | 20 mg | — |
| Subject | Naproxen | Small molecule | 500 mg | — |