CR4056-2-01

• Research type

  Research Study

• Full title

  A randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy, safety and tolerability of CR4056 administered for 2 weeks in patients with osteoarthritis of the knee with moderate to severe chronic pain (with or without a neuropathic component)

• IRAS ID

  182870

• Contact name

  Nicholas Jon Probert

• Contact email

  nickprobert@macplc.com

• Sponsor organisation

  Rottapharm Biotech S.r.l.

• Eudract number

  2015-001136-37

• Duration of Study in the UK

  0 years, 9 months, 0 days

• Research summary

  Osteoarthritis (OA) is the most common form of arthritis that affects both small and large joints. Chronic pain is the most prominent symptom in patients with OA, and is associated with significant disability. The aim of this study is to obtain the proof about the analgesic effect of CR4056 in patients with knee osteoarthritis with or without a neuropathic pain component and to evaluate its safety profile. Neuropathic pain means pain caused by damaged nerves supplying the painful area.
  Patients fulfilling randomization criteria will be randomly allocated to one of the 3 treatment arms to receive CR4056 200 mg or 100 mg, or matching placebo, for 14 days. The medication will be taken twice per day for a total daily dose of either 400mg, 200mg or 0mg in placebo arm.
  

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  15/SC/0407

• Date of REC Opinion

  19 Aug 2015

• REC opinion

  Further Information Favourable Opinion