Abstract | BACKGROUND: METHODS: In this Phase-2, double-blind, multicenter study, 228 patients with moderate to severe knee osteoarthritis pain were randomized to a single intra-articular injection of FX006 (containing 10, 40, or 60 mg of triamcinolone acetonide) or 40 mg of immediate-release triamcinolone acetonide. Data on the mean daily pain on the 11-point Numeric Rating Scale were collected over twelve weeks; the primary efficacy end point was the change from baseline to each of eight, ten, and twelve weeks in the weekly mean of the mean daily pain intensity scores analyzed with a longitudinal mixed-effects model. RESULTS: The 10-mg dose of FX006 produced pain relief that was improved relative to immediate-release triamcinolone acetonide at two through twelve weeks, although the difference in pain relief was not significant (p ≥ 0.05). The 40-mg dose of FX006 produced pain relief that was improved at two through twelve weeks and was significantly superior to immediate-release triamcinolone acetonide at five to ten weeks (p < 0.05 at each time point). At the 40-mg dose of FX006, prespecified secondary analyses, including responder analyses and all Western Ontario and McMaster Universities subscales, were significantly superior (p < 0.05) to immediate-release triamcinolone acetonide at eight weeks, and the time-weighted mean pain relief (assessed with mean daily pain intensity scores) was significantly superior to immediate-release triamcinolone acetonide over one to twelve weeks (p = 0.04). The 60-mg dose did not provide additional improvement relative to the 40-mg dose. Adverse events were generally mild and similar across all treatments. CONCLUSIONS: LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
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Authors | Neil Bodick, Joelle Lufkin, Christina Willwerth, Anjali Kumar, James Bolognese, Chris Schoonmaker, Rahul Ballal, David Hunter, Michael Clayman |
Journal | The Journal of bone and joint surgery. American volume
(J Bone Joint Surg Am)
Vol. 97
Issue 11
Pg. 877-88
(Jun 03 2015)
ISSN: 1535-1386 [Electronic] United States |
PMID | 26041848
(Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Copyright | Copyright © 2015 by The Journal of Bone and Joint Surgery, Incorporated. |
Chemical References |
- Analgesics
- Anti-Inflammatory Agents
- Delayed-Action Preparations
- Triamcinolone Acetonide
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Topics |
- Analgesics
(administration & dosage)
- Anti-Inflammatory Agents
(administration & dosage)
- Delayed-Action Preparations
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Humans
- Injections, Intra-Articular
- Male
- Middle Aged
- Musculoskeletal Pain
(prevention & control)
- Osteoarthritis, Knee
(drug therapy)
- Treatment Outcome
- Triamcinolone Acetonide
(administration & dosage)
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