Arcoxia in Patients with Moderate to Severe Neuropathic Pain Version 1

• Research type

  Research Study

• Full title

  An Enriched Enrollment, Double Blind, Placebo-Controlled, Parallel Group, Randomized Withdrawal Trial to Evaluate the Efficacy, Tolerability and Safety of Etoricoxib (Arcoxia) in Patients with Moderate to Severe Neuropathic Pain

• IRAS ID

  61332

• Contact name

  stuartratcliffe

• Sponsor organisation

  Analgesic Solutions

• Eudract number

  2010-022873-32

• Research summary

  Neuropathic pain (NP) remains undertreated. Guidelines based on evidence and/or expert consensus have reflected that Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are not effective for the treatment of NP, however a number of more recent lines of evidence suggest they could be effective. Etoricoxib is approved in over 70 countries for the treatment of acute and chronic pain, primarily due to inflammatory joint disease. Therefore the aim of this study is to determine the safety and efficacy of etoricoxib, an NSAID analgesic, in patients with neuropathic pain. Approximately 120 male and female patients aged 18 and over will be recruited in the UK. Of these it is expected 90 patients will enter a two week open-label period, and of these 40 will enter a four week double-blind period. The duration of the study will be approximately eight weeks, and will involve four visits to the clinic. Patients will be followed by telephone calls twice during the study. The first call will be during the double blind phase and the second approximately one week after their final visit. Patients will receive the medication for up to six weeks. Patients will be asked to evaluate their pain via questionnaires and sensory testing procedures. Other assessments will include vital signs, physical examination, blood sampling and urinalysis (if no recent results are available).

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  10/H1003/103

• Date of REC Opinion

  14 Dec 2010

• REC opinion

  Further Information Favourable Opinion