Osteoarthritis Clinical Trial
Official title:
Maxi-Analgesic OA Study: Multicentre, Double-blind, Placebo-controlled, Randomized, Parallel Group Comparison of the Effects of Maxigesic 325 With Acetaminophen or Ibuprofen on Patients With Pain From Osteoarthritis
The purpose of this study is to determine whether the analgesic effects of Maxigesic USA are greater than acetaminophen, ibuprofen or placebo in patients who have painful osteoarthritis of the hip or knee.
Osteoarthritis is a significant and disabling disease in the developed world.
Published guidelines for medical management of osteoarthritis from expert groups, in general
advocate acetaminophen as first line treatment. The European League Against Rheumatism
(EULAR) guidelines (1)recommend acetaminophen should be first choice therapy in OA, and that
NSAIDs should be reserved for those patients unresponsive to acetaminophen. The American
College of Rheumatology Guidelines (2) recommend acetaminophen be considered as reasonable
initial therapy in patients with mild to moderate OA pain and that NSAIDs be considered as
an initial alternative in moderate to severe OA pain. The Canadian guidelines recommend
acetaminophen for mild OA pain and NSAIDs for moderate to severe OA (3).
A Cochrane Review of acetaminophen in osteoarthritis concluded that NSAIDs were superior to
acetaminophen for improving knee and hip pain in people with OA. However, it was noted that
the size of the treatment effect was modest with NSAIDs appearing to be more effective in OA
subjects with moderate-to-severe pain (4).
There are many situations in clinical practice where either acetaminophen alone or low dose
ibuprofen is not sufficiently effective. In these cases the dose of acetaminophen cannot be
increased to more than 4000mg/day due to toxicity concerns. In the case of ibuprofen the
dose can be increased from 1200mg/day to 2400mg/day. However comparison of low dose
ibuprofen with high dose showed gastrointestinal (GI) toxicity increased: the relative risk
(RR) of GI complications increased from 1.6 (95% CI 0.8, 3.2) with low dose ibuprofen to 4.2
(95% CI 1.8, 9.8) with high dose ibuprofen (5). Ibuprofen is associated with a low risk of
serious gastrointestinal complications, but this advantage is probably lost at doses above
1800 mg/day (6).
A simple combination treatment whereby both acetaminophen and ibuprofen can be taken
together as one single tablet and at the same time each day would, if effective, have the
advantage of increasing analgesia without having to raise the ibuprofen dose above
1200mg/day (1170mg if administered every 6 hours) and lose the improved safety profile
associated with a lower dose of ibuprofen.
1. Pendleton A, Arden N, Dougados M, Doherty M, Bannwarth B, Bijlsma JW, et al. EULAR
recommendations for the management of knee osteoarthritis: report of a task force of
the Standing Committee for International Clinical Studies Including Therapeutic Trials
(ESCISIT). Ann Rheum Dis. 2000;59(12):936-44.
2. Recommendations for the medical management of osteoarthritis of the hip and knee: 2000
update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines.
Arthritis Rheum. 2000;43(9):1905-15.
3. Tannenbaum H, Peloso PM, Russell AS, Marlow B. An evidence-based approach to
prescribing NSAIDs in the treatment of osteoarthritis and rheumatoid arthritis: The
Second Canadian Consensus Conference. Can J Clin Pharmacol. 2000;7 Suppl A:4A-16A.
4. Towheed TE, Maxwell L, Judd MG, Catton M, Hochberg MC, Wells G. Acetaminophen for
osteoarthritis. Cochrane Database Syst Rev. 2006(1):CD004257.
5. Henry D, Lim LLY, Garcia Rodriguez LA, Perez Gutthann S, Carson JL, Griffin M, et al.
Variability in risk of gastrointestinal complications with individual non-steroidal
anti-inflammatory drugs: Results of a collaborative meta-analysis. British Medical
Journal. 1996;312 (7046):1563-6.
6. Henry D, McGettigan P. Epidemiology overview of gastrointestinal and renal toxicity of
NSAIDs. Int J Clin Pract Suppl. 2003;Supplement.(135):43-9.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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