Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-01-04 @ 7:41 PM
Study NCT ID:
NCT01420666
Status:
WITHDRAWN
Last Update Posted:
2016-01-06
First Post:
2011-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maxi-Analgesic Osteoarthritis (OA) Study
Sponsor:
AFT Pharmaceuticals, Ltd.
Organization:
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was withdrawn for administrative reason
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: