Tapentadol PR & IR, V3.0 (KF 43) for OA of the knee (study 2)

• Research type

  Research Study

• Full title

  An evaluation of the effectiveness and tolerability of tapentadol hydrochloride prolonged release, and tapentadol hydrochloride immediate release on demand, in subjects severe chronic pain due to osteoarthritis of the knee taking either WHO Step III analgesics but showing a lack of tolerability.

• IRAS ID

  21834

• Contact name

  Karen Simpson

• Eudract number

  2009-010425-39

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is a 13 week, phase IIIb study. 180 subjects with severe chronic pain due to OA of the knee will be enrolled in this multicentre, multinational, open label study. The primary objective is to evaluate the effectiveness, tolerability and safety of tapentadol hydrochloride PR in subjects with chronic pain due to OA of the knee pretreated with WHO Step III opioids but showing lack of tolerability. To also demonstrate the potential reduction in the need for WHO Step I analgesics under tapentadol hydrochloride PR treatment. To also evaluate a potential reduction in the need for medication (antiemetics and laxatives) to treat opioid-related adverse events in subjects previously treated with WHO III opioid analgesics. The main inclusion criteria for this study are participants who are at least 40 years of age and whose pain requires strong analgesia (defined by WHO III). Subjects must report a rate of satisfaction with previous analgesic regimen not exceeding fair. Subjects must be taking Step III analgesic on a daily basis for at least 2 weeks prior to the screening visit and report opioid related side effects as the reason for changing their analgesics. This is one of four studies looking at the tapentadol hydrochloride PR and IR (immediate release) as an alternative WHO Step III analgesic.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  09/H0402/77

• Date of REC Opinion

  23 Sep 2009

• REC opinion

  Further Information Favourable Opinion