Tapentadol PR & IR, V3.0 (KF 42)for OA of the knee (study 1)

• 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 with uncontrolled severe chronic pain due to osteoarthritis of the knee taking either WHO Step I or Step II analgesics or no regular analgesics.

• IRAS ID

  21268

• Contact name

  Barbara Hoggart

• Sponsor organisation

  Grunenthal

• Eudract number

  2009-010423-58

• ISRCTN Number

  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 prolonged release (PR) in subjects with chronic pain due to osteoarthritis of the knee. To also demonstrate that tapentadol hydrochloride PR produces a better analgesia then Step I and Step II analgesics, and also to evaluate if it can reduce the need for WHO 1 analgesics. Tapentadol has favourable side effects and its administration may reduce the need for medication such as anti-emetics and laxatives routinely prescribed for the treatment of the side effects typically produced by opioids. The main inclusion criteria for this study are participants who are at least 40 years of age and whose pain requires stronger analgesia (defined by WHO III). Subjects must report a rate of satisfaction with their previous analgesic regimen not exceeding fair. Subjects must be taking a WHO Step I or Step II analgesics medication for Osteroarthritis of the knee on a daily basis for at least 2 weeks prior to the screening visit. The investigator considers dose increase of WHO Step I analgesics and/or continuation with or dose increase of WHO Step II analgesics inadequate for the individual subjects. This is one of four studies looking at the tapentadol hydrochloride PR and IR (immediate release) as alternative WHO Step III analgesic.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  09/H1306/75

• Date of REC Opinion

  28 Aug 2009

• REC opinion

  Further Information Favourable Opinion