ONO-4474-02 Study to evaluate the efficacy of ONO-4474 in patients
Research type
Research Study
Full title
A randomised, double-blind, placebo controlled, parallel group, multi-centre, study to evaluate the efficacy, safety, tolerability and pharmacokinetics of ONO-4474 in patients with pain due to osteoarthritis of the knee
IRAS ID
214615
Contact name
Philip Conaghan
Contact email
Sponsor organisation
Ono Pharmaceutical Co., Ltd.
Eudract number
2016-002675-97
Clinicaltrials.gov Identifier
31843, Registration of Study
Duration of Study in the UK
0 years, 11 months, days
Research summary
Current treatments for osteoarthritis pain are associated with significant side effects. The research medicine, ONO-4474, is expected to have analgesic effects on patients with osteoarthritis pain of the knee with fewer side effects than current available treatments.The main purpose of this study is to see if ONO-4474 helps to relieve the pain associated with osteoarthritis of the knee. The company sponsoring this study would also like to know if ONO-4474 is safe and that any side effects associated with its use are manageable.
There is no cure available for Osteoarthritis (OA) and it poses a significant health burden to patients and the health service. Effective pain management is still an unmet need.
Effective pain relief is required as an alternative to morphine based products and NSAIDs, which are associated with significant side-effects.
ONO-4474 is a pan-Trk (Tropomoysin-receptor kinase) inhibitor being developed for the treatment of musculoskeletal pain. This Proof of Concept study will investigate the efficacy, safety, tolerability and pharmacokinetics (PK) of ONO-4474 in patients with moderate/severe Osteoarthritis of the knee following 4 weeks administration of ONO-4474.
Male and female (non-child bearing potential) patients of 40 to 75 years inclusive experiencing moderate-severe OA knee pain in accordance with the American College of Rheumatology classification system would be eligible for screening for suitability to enter the study.
Approximately 280 patients will be randomised into the study. Approximately 10 sites are planned for the UK with a total of 80 UK patients.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
16/EE/0444
Date of REC Opinion
21 Nov 2016
REC opinion
Further Information Favourable Opinion