A phase 3 randomised, double-blind, placebo-controlled, multicentre study of the analgesic efficacy and safety of the subcutaneous administration of tanezumab in subjects with osteoarthritis of the hip or knee This is a randomized, double‑blind, placebo‑controlled, parallel‑group multicenter study of the efficacy and safety of tanezumab when administered by SC injection for 24 weeks compared to placebo in subjects with osteoarthritis of the knee or hip. The study is designed with a total post-randomization duration of 48 weeks and will consist of three periods: Screening (up to 37 days), Double-blind Treatment (24 weeks) and Safety Follow-up (24 weeks). The primary objective of this study is to demonstrate superior efficacy of tanezumab 5 mg and 2.5 mg administered subcutaneously (SC) every 8 weeks versus placebo at Week 24, with the secondary one of evaluating safety of tanezumab at those doses. Chief Investigator: Dr Philip Riches Number and location of participating sites (by region/ country): International multicentre trial approx. 810 patients EudraCT number: 2013-004508-21 Funder: Pfizer Start and End date of grant award: Sep 2016 -Sep 2018 Current Status: Completed Trial Unblinding Information: Available Contact Information / Sponsor: Pfizer Dr David Walker, Pfizer Inc. Clinical Team: Debbie Alexander and Morag Charles ECTU Involvement: Clinical support – research nurses This article was published on 2024-09-24
