Long-term observational study of subjects from Tanezumab studies
Research type
Research Study
Full title
A PHASE 3, MULTICENTER, LONG-TERM OBSERVATIONAL STUDY OF SUBJECTS FROM TANEZUMAB STUDIES WHO UNDERGO A TOTAL KNEE, HIP OR SHOULDER REPLACEMENT
IRAS ID
189134
Contact name
Christine West
Contact email
Sponsor organisation
Pfizer Inc, 235 East 42nd Street, New York, NY 10017
Eudract number
2013-002549-12
Duration of Study in the UK
2 years, 6 months, 16 days
Research summary
This is a long-term observational study of subjects from Tanezumab Studies who undergo a total knee, hip or shoulder replacement during participation in their Tanezumab Study (treatment period or safety followup period). The purpose of it is to gather information on pain, function, satisfaction and additional or corrective procedures. There is no study medication in this observational study and study data will be collected via interviews and questionnaires. This study is designed with a total duration of subject follow-up of 24 weeks after the total joint replacement surgery. It is estimated that approximately 250 people will take part in this study. The study is being done at approximately 496 different research sites in approximately 25 countries.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
16/NE/0097
Date of REC Opinion
23 May 2016
REC opinion
Further Information Favourable Opinion