Safety and Efficacy of 2PX in patients with Osteoarthritis of the knee

• Research type

  Research Study

• Full title

  A 26 week placebo-controlled, randomised, double-blind, parallel group study of the efficacy and safety of 2PX (topical strontium chloride hexahydrate) in patients with pain due to osteoarthritis of the knee.

• IRAS ID

  19377

• Sponsor organisation

  SantoSolve A/S

• Eudract number

  2008-008593-31

• ISRCTN Number

  0

• Clinicaltrials.gov Identifier

  0

• Research summary

  This trial will be conducted as a multi-centre, randomised, double-blind, parallel-group study, in patients with chronic, moderate to severe osteoarthritis pain of the knee. The investigational therapy in this study is 2PX (10% strontium chloride hexahydrate) solution for topical administration and will be compared to placebo ((vehicle; identical to the test article without the 10% strontium chloride hexahydrate).The study will last for approximately 26 weeks and will include a total of 7 study visits at the investigational site.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  09/H1010/14

• Date of REC Opinion

  10 Jun 2009

• REC opinion

  Further Information Favourable Opinion