drugset / Trial / NCT03199417
Trial Evaluating multimOdal toPical Cream In CompArison to pLacebo (TOPICAL)
Phase 2/3
Terminated
50 enrolled
University of Michigan
McMaster University · collabOakville Trafalgar Memorial Hospital · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Randomized controlled trial regarding the efficacy of a multimodal topical analgesic, Multiprofen, in comparison to placebo cream treatment on knee pain and function in patients with knee osteoarthritis.
Timeline
- Start
- 2017-05-01
- Primary completion
- 2018-05-30
- Completion
- 2018-05-30
Publications
- Background Tarride JE, Haq M, O'Reilly DJ, Bowen JM, Xie F, Dolovich L, Goeree R. The excess burden of osteoarthritis in the province of Ontario, Canada. Arthritis Rheum. 2012 Apr;64(4):1153-61. doi: 10.1002/art.33467. Epub 2011 Nov 11.
- Background Rannou F, Pelletier JP, Martel-Pelletier J. Efficacy and safety of topical NSAIDs in the management of osteoarthritis: Evidence from real-life setting trials and surveys. Semin Arthritis Rheum. 2016 Feb;45(4 Suppl):S18-21. doi: 10.1016/j.semarthrit.2015.11.007. Epub 2015 Dec 2.
- Background Stanos SP, Galluzzi KE. Topical therapies in the management of chronic pain. Postgrad Med. 2013 Jul;125(4 Suppl 1):25-33. doi: 10.1080/00325481.2013.1110567111.
- Background Argoff CE. Topical analgesics in the management of acute and chronic pain. Mayo Clin Proc. 2013 Feb;88(2):195-205. doi: 10.1016/j.mayocp.2012.11.015.
- Background Williams VJ, Piva SR, Irrgang JJ, Crossley C, Fitzgerald GK. Comparison of reliability and responsiveness of patient-reported clinical outcome measures in knee osteoarthritis rehabilitation. J Orthop Sports Phys Ther. 2012 Aug;42(8):716-23. doi: 10.2519/jospt.2012.4038. Epub 2012 Mar 8.
- Background Katz NP, Paillard FC, Ekman E. Determining the clinical importance of treatment benefits for interventions for painful orthopedic conditions. J Orthop Surg Res. 2015 Feb 3;10:24. doi: 10.1186/s13018-014-0144-x.
- Background Jabbari M, Hashempur MH, Razavi SZ, Shahraki HR, Kamalinejad M, Emtiazy M. Efficacy and short-term safety of topical Dwarf Elder (Sambucus ebulus L.) versus diclofenac for knee osteoarthritis: A randomized, double-blind, active-controlled trial. J Ethnopharmacol. 2016 Jul 21;188:80-6. doi: 10.1016/j.jep.2016.04.035. Epub 2016 Apr 26.
- Results Fernandez-Lopez JC, Laffon A, Blanco FJ, Carmona L; EPISER Study Group. Prevalence, risk factors, and impact of knee pain suggesting osteoarthritis in Spain. Clin Exp Rheumatol. 2008 Mar-Apr;26(2):324-32.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amitryptiline | Unknown | — | Topical |
| Subject | Baclofen | Small molecule | — | Topical |
| Subject | Ketoprofen | Small molecule | — | Topical |
| Subject | Lidocaine | Other / unclassified | — | Topical |