Efficacy & Safety of TANEZUMAB in subjects Osteoarthritis of Hip/Knee
Research type
Research Study
Full title
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF THE SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE
IRAS ID
184471
Contact name
Dr David Walker
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2013-004508-21
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This study is investigating an experimental drug called TANEZUMAB (PF-04383119) that is being developed for use in the treatment of chronic pain. The purpose of this research is to compare the effects of this investigational drug with a placebo to find out which is better for treating pain due to osteoarthritis and of the hip or knee. Approximately 810 patients from about 15 countries who meet the eligibility requirements will take part in this study. Patients will be randomly assigned 1:1:1 (approximately 270 per group) to receive one of two doses of investigational drug PF-04383119 (2.5mg or 5mg) or matching placebo. A total of 3 subcutaneous injections will be given, separated by 8 weeks in addition to background opioids administered throughout the study. Patients will be expected to participate in this research study for just over 1 year. The study will consist of three periods: a Pre Treatment Period (which can last up to 37 days) a 24 week Treatment period, and a 6-month follow-up Period.
In addition, participants will be asked to allow the collection of small (4mL) blood sample at the first visit of the treatment period. Also known as pharmacogenomics or biomarker this sample can potential be used in future studies, while associated with chronic pain and related conditions. Hence the sample ‘banked biospecimens’ will be kept by Pfizer for many years (no time limit).
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
16/NE/0050
Date of REC Opinion
22 Apr 2016
REC opinion
Further Information Favourable Opinion