Safety and Efficacy of PRX167700 in Patients with Knee Osteoarthritis
Research type
Research Study
Full title
A Randomised, Parallel Arm, Placebo-Controlled, Double-Blind, Study of the Safety and Efficacy of PRX167700 Added to Existing Non-steroidal Anti-inflammatory Therapy in Adults with Moderate-to-Severe Knee Pain Due to Osteoarthritis
IRAS ID
211241
Contact name
Aliya Asher
Contact email
Sponsor organisation
Proximagen Ltd
Eudract number
2016-001443-39
Duration of Study in the UK
0 years, 9 months, 30 days
Research summary
This research study is being done by a Sponsor company called "Proximagen Limited". The drug being studied is called PRX167700. PRX167700 is a new anti-inflammatory drug, which inhibits an enzyme (type of protein) called 'SSAO' found in blood and it may be useful as a treatment for chronic inflammatory conditions such as osteoarthritis (OA).
Osteoarthritis (OA) is a progressive degenerative joint disease affecting cartilage and subchondral bone and is a common cause of chronic pain. As OA progresses, the affected joints appear larger, stiff and painful, and usually feel better with gentle use but worse with excessive or prolonged use.
The purpose of this research study is to find out how well PRX167700 works in reducing symptoms of knee pain in subjects with moderate to severe OA, when taken for 6 weeks in subjects who are on a stable daily dose of a non-steroidal anti-inflammatory drug (NSAID). In addition, this study will also find out how safe the drug is (by looking at side effects) and how it is absorbed and processed by the body.
The length of participation is this study is approximately 9 to 12 weeks and it will involve a total of 9 study visits. As part of this study, participants will undergo, physical and neurological assessments, as well as blood and urine
sampling for laboratory analysis, ECGs and an X-ray of the target knee if a report is not available within 12 months prior to screening, for eligibility purposes. Patients will be asked to will be asked to complete an electronic diary and wear an activity monitor (like a wrist watch) every day from Visit 2 to Visit 8. Patients will also be asked to complete questionnaires on an electronic tablet device (like a handheld computer screen) at certain visits.REC name
East Midlands - Derby Research Ethics Committee
REC reference
16/EM/0335
Date of REC Opinion
23 Sep 2016
REC opinion
Further Information Favourable Opinion