MK-0663/Etoricoxib in Patients With Ankylosing Spondylitis

• Research type

  Research Study

• Full title

  A Phase III, Two-Part, Randomised, Double-Blind, Active Comparator-Controlled, Multicentre Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis

• IRAS ID

  59127

• Contact name

  Andrew Ostor

• Sponsor organisation

  Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

• Eudract number

  2010-019872-65

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Ankylosing spondylitis (AS), a form of Spondyloarthritis (inflammatory joint diseases of the vertebral column) is a chronic, inflammatory arthritis and autoimmune disease with a strong genetic predisposition. It mainly affects joints in the spine and the sacroilium in the pelvis, and can cause eventual fusion of the spine. No cure is known for AS, although treatments and medications are available to reduce symptoms and pain. The most frequent symptom is spinal pain, especially at night and upon awakening. Anti-inflammatory drugs such as NSAIDs (such as aspirin and ibuprofen) and COX-2 inhibitors are important to reduce both, analgesic and anti-inflammatory properties. A recent review from several studies shows that they are effective against spinal pain, peripheral joint pain and improving function. NSAIDs are the primary therapy for many AS patients suffering from daily pain. However, the adverse effects of NSAIDs have become increasingly prevalent. Traditional NSAIDs are often related to direct and indirect irritation of the gastrointestinal (GI) tract. They range from symptoms like dyspepsia (upset stomach or indigestion), abdominal pain and nausea to even serious upper GI clinical events like perforation (small hole or tear), obstruction, bleeding or ulcer, that need additional medical care. Etoricoxib is a COX-2 selective inhibitor, which has shown to provide efficacy comparable to traditional NSAIDs, but with an improved GI safety profile, when comparing rates of upper GI clinical events. In a previous study etoricoxib 90 mg was determined as the minimal dose with maximal efficacy in rheumatoid arthritis and AS. However, 60 mg has never been tested in AS, and it is possible it could be an effective dose. This trial compares the efficacy of etoricoxib 90 mg and 60 mg and compares the clinical efficacy of these etoricoxib doses to the NSAID naproxen 1000 mg.This is a randomised, double-blind, active comparator-controlled trial meaning neither the investigator nor the patient knows which medication is being given. This multicentre clinical trial, sponsored by Merck & Co., Inc. will take place in several countries worldwide recruiting approximately 1300 patients.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  10/H0308/88

• Date of REC Opinion

  1 Dec 2010

• REC opinion

  Further Information Favourable Opinion