Safety,Efficacy,Tolerability Study of 2PX in Chronic Stump Pain

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo (vehicle) controlled, parallel group study of the efficacy, safety and tolerability of topical 2PX (strontium chloride hexahydrate) in patients with chronic, moderate-to-severe lower limb post-amputation stump pain.

• IRAS ID

  6552

• Sponsor organisation

  SantoSolve A/S

• Eudract number

  2008-002655-24

• Research summary

  This trial will be conducted as a multi-centre, randomised, double-blind, parallel-group study, in patients with chronic, moderate to severe lower limb post -amputation stump pain. The investigational therapy in this study is 2PX (10% strontium chloridehexahydrate) solution for topical administration and will be compared to placebo (vehicle; identical to the test article without the 10% strontiumchloride hexahydrate). The study will last for approximately 14 weeks and will include a total of 4 study visits at the investigational site and 3 follow-up visits conducted on the telephone.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  08/H1008/135

• Date of REC Opinion

  24 Oct 2008

• REC opinion

  Further Information Favourable Opinion