Safety & Efficacy of PRX167700 in Patients with Knee Osteoarthritis
Research type
Research Study
Full title
A Randomized, Double Dummy, Parallel Arm, Placebo and Active Controlled, Double Blind, Study of the Safety and Efficacy of PRX167700 as Monotherapy in Adults with Moderate to Severe Knee Pain Due to Osteoarthritis who are Inappropriate for Oral Nonsteroidal Anti inflammatory Therapy
IRAS ID
226350
Contact name
Aliya Asher
Contact email
Sponsor organisation
Proximagen Ltd
Eudract number
2017-001185-20
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 (the layer of bone just below the cartilage which acts as a shock absorber in a joint) 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, who are deemed inappropriate for oral non-steroidal anti-inflammatory (NSAID) drugs by their physician. 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, blood and urine tests 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 complete an electronic diary to record their levels of pain 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
17/EM/0348
Date of REC Opinion
21 Nov 2017
REC opinion
Further Information Favourable Opinion