Effect of BTDS on activity in patients with osteoarthritis of the knee

• Research type

  Research Study

• Full title

  An open label, randomised two part crossover study to investigate the effect of buprenorphine transdermal delivery system (BTDS) compared with co-codamol on physical activity in subjects aged 60 years of age or over with knee pain secondary to osteoarthritis.

• Sponsor organisation

  Newcastle Upon Tyne NHS Foundation Trust

• Eudract number

  2007-002357-23

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Osteoarthritis is a disease which affects the joints in the body. The damaged joints can be swell, cause pain and difficulty with movement. Treatments for osteoarthritis focus on pain relief to allow greater activity. Current therapies include non-steroidal ant-inflammatories (NSAIDs) and painkillers such as paracetamol. It appears that osteoarthritis increases in prevalence in an aging population stressing the need to find more effective therapies for the control of pain in osteoarthritis.This study will help us to evaluate the effectiveness of the Buprenorphine Transdermal System (BTDS skin patch) compared to Co-codamol on the physical activity of subjects > 60 years of age with knee pain secondary to osteoarthritis. The potential benefit to the subject would be to increase their activity by decreasing their pain. Each subject will take part in 2 arms of the study. They will be prescribed either BTDS or Co-codamol in the first arm. They will receive increasing doses of the medication on a weekly basis until their optimum pain control is reached. Once achieved, they will stay on this dose for 6 weeks. On the second arm of the study, those subjects who received BTDS on the first arm will crossover to Co-codamol and similarly those subjects who received Co-codamol on the first arm of the study will receive BTDS on the second arm. The titration process is repeated. There will be one week washout period between the 2 arms of the study. Throughout the study, the subjects will be required to complete questionnaires on their quality of life, sleep pattern and pain. They will wear activity monitors between to 6 times during the course of the study and will be asked to fill in daily diaries recording pain and sleep.NAPP Pharmaceuticals are funding the research and the study will be held at The Freeman Hospital, Newcastle Upon Tyne.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  08/H0907/117

• Date of REC Opinion

  11 Dec 2008

• REC opinion

  Further Information Favourable Opinion