Exploratory Study of PRX167700 in Subjects with Knee Osteoarthritis

• Research type

  Research Study

• Full title

  A Double-Blind, Randomised, Exploratory Study to Investigate the Safety, Efficacy and Pharmacokinetics of PRX167700 in Subjects with Knee Osteoarthritis.

• IRAS ID

  132061

• Contact name

  Essam Abdulhakim

• Contact email

  Essam.hakim@synexus.com

• Sponsor organisation

  Proximagen Limited

• Eudract number

  2013-001970-33

• Research summary

  This study will evaluate a new anti-inflammatory drug, PRX167700, in subjects with painful osteoarthritis of the knee. The purpose of this study is to investigate if PRX167700 improves the pain from osteoarthritis of the knee, and to assess its safety and tolerability. The study will also investigate how PRX167700 is distributed and broken down in the body.
  Up to 74 subjects will receive either PRX167700 or placebo (a dummy treatment) for 15 days. Subjects will need to stop taking their usual pain reliever medicines for at least 7 days before starting treatment to induce a ’flare’ in osteoarthritis symptoms (but they will be allowed to continue to use paracetamol for immediate pain relief as needed throughout the trial). The effect of PRX167700 or placebo on knee pain will be assessed before and after exercise on Days 1, 3, 7 and 14. On Day 15, blood samples will be collected to measure levels of PRX167700 and assess its activity.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  13/NW/0490

• Date of REC Opinion

  18 Jul 2013

• REC opinion

  Further Information Favourable Opinion