drugset / Trial / NCT02357459
Study of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study was to assess the safety and efficacy of FX006 for the treatment of pain in patients with osteoarthritis of the knee.
Timeline
- Start
- 2015-01
- Primary completion
- 2016-01
- Completion
- 2016-01
Outcome
Met primary endpoint
registry analysis (superiority test); FX006 32mg vs Placebo; p <0.0001; Mean Difference (Final Values) -0.98 (95% CI -1.47 to -0.49) NCT02357459 ↗
Publications
- Ross E, Katz NP, Conaghan PG, Kivitz A, Turk DC, Spitzer AI, Jones DG, Lanier RK, Cinar A, Lufkin J, Kelley SD. Improved Treatment Effect of Triamcinolone Acetonide Extended-Release in Patients with Concordant Baseline Pain Scores on the Average Daily Pain and Western Ontario and McMaster Universities Osteoarthritis Index Pain Scales. Pain Ther. 2022 Mar;11(1):289-302. doi: 10.1007/s40122-021-00335-z. Epub 2021 Nov 17.
- Langworthy MJ, Conaghan PG, Ruane JJ, Kivitz AJ, Lufkin J, Cinar A, Kelley SD. Efficacy of Triamcinolone Acetonide Extended-Release in Participants with Unilateral Knee Osteoarthritis: A Post Hoc Analysis. Adv Ther. 2019 Jun;36(6):1398-1411. doi: 10.1007/s12325-019-00944-3. Epub 2019 Apr 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tafamidis | Unknown | 32 mg | Other |
| Subject | Triamcinolone Acetonide | Other / unclassified | 40 mg | Other |