Tanezumab In Osteoarthritis Of The Hip Or Knee

Summary

The purpose of the study is to test the efficacy and safety of 2 doses of tanezumab compared to oxycodone CR and placebo in patients with osteoarthritis

Timeline

Start

2009-10-30

Primary completion

2010-12-13

Completion

2011-02-04

Outcome

Met primary endpoint

Stopped: “See termination reason in detailed description.”

registry analysis (unspecified test); Placebo vs Tanezumab 5 mg; p <0.001; Least Squares (LS) Mean Difference -0.96 (95% CI -1.49 to -0.44); ANCOVA NCT00985621 ↗

registry analysis (unspecified test); Tanezumab 5 mg vs Oxycodone CR; p <0.001; LS Mean Difference -0.97 (95% CI -1.49 to -0.45); ANCOVA NCT00985621 ↗

Publications

• Brown MT, Cornblath DR, Koltzenburg M, Gorson KC, Hickman A, Pixton GC, Gaitonde P, Viktrup L, West CR. Peripheral Nerve Safety of Nerve Growth Factor Inhibition by Tanezumab: Pooled Analyses of Phase III Clinical Studies in Over 5000 Patients with Osteoarthritis. Clin Drug Investig. 2023 Jul;43(7):551-563. doi: 10.1007/s40261-023-01286-3. Epub 2023 Jul 18.
• Tive L, Bello AE, Radin D, Schnitzer TJ, Nguyen H, Brown MT, West CR. Pooled analysis of tanezumab efficacy and safety with subgroup analyses of phase III clinical trials in patients with osteoarthritis pain of the knee or hip. J Pain Res. 2019 Mar 19;12:975-995. doi: 10.2147/JPR.S191297. eCollection 2019.
• Spierings ELH, Fidelholtz J, Wolfram G, Smith MD, Brown MT, West CR. A phase III placebo- and oxycodone-controlled study of tanezumab in adults with osteoarthritis pain of the hip or knee. Pain. 2013 Sep;154(9):1603-1612. doi: 10.1016/j.pain.2013.04.035. Epub 2013 Apr 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Oxycodone	Other / unclassified	10 mg	—
Comparator	Oxycodone	Other / unclassified	40 mg	—
Subject	Tanezumab	Monoclonal antibody	5 mg	—
Subject	Tanezumab	Monoclonal antibody	10 mg	—

Indications