Trial Evaluating multimOdal toPical Cream In CompArison to pLacebo (TOPICAL)
NCT ID: NCT03199417
Last Updated: 2019-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
50 participants
INTERVENTIONAL
2017-05-01
2018-05-30
Brief Summary
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Detailed Description
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Conservative treatment options include topical and oral anti-inflammatory medications, weight loss, physiotherapy and intra articular cortisone and viscosupplementation injections. Unfortunately, commonly used treatments such as oral anti-inflammatory medications carry a significant systemic adverse effect on the gastrointestinal (GI) tract and hepatic and renal systems and intra articular cortisone have potential adverse effect on blood glucose control. For this reason, topical anti-inflammatory medications are popular yet are often ineffective. Unfortunately, topical anti-inflammatory medications have variable efficacy in relieving osteoarthritic knee pain and often only provide a moderate degree of pain relief.
In the setting of chronic pain various other topical modalities have been utilized. A systematic review of the literature identified commonly studied topical analgesics were nonsteroidal anti-inflammatory drugs followed by lidocaine, capsaicin, amitriptyline, glyceryl trinitrate, opioids, menthol, pimecrolimus, and phenytoin. Given the biological bases behind utilizing agents which target a variety of pain generators the investigators hypothesized that a combination of these would provide significant pain relief to patients affected by end stage knee osteoarthritis. For this reason, the investigators propose a trial evaluating utilizing multiple topical modalities for pain relief to provide support for the use of combination therapy in treating knee osteoarthritis. Results from this study will potentially improve the global health and economic burden through improvement in the management of knee osteoarthritis.
STUDY OBJECTIVES
Primary objective The primary objective of the trial will be to evaluate the efficacy of a multimodal topical analgesic, Multiprofen, in comparison to placebo cream treatment on patient reported pain relief utilizing a 11-point visual analog scale (VAS) measured from 0-10.
Secondary objectives
Our secondary objectives will be to evaluate the effect of topical combination therapy on:
1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) patient reported outcome score. This score is commonly utilized in assessment of knee osteoarthritis and has been validated to be reliable and responsive in this patient population.
2. Patient knee range of motion and strength
3. Return to previous level of activity
4. Radiographic degree of osteoarthritis.
5. Patient demographics
6. Adverse events
SUMMARY OF TRIAL DESIGN The investigators propose a single center blinded trial evaluating the efficacy of a combination formula of topical analgesic in comparison to placebo cream treatment. The investigators will randomize 186 patients between topical multimodal cream "multiprofen" and a control placebo cream.
Randomization Method Participants will be randomized using a random number generator to either experimental or placebo control intervention.
Participants will be randomized to one of two treatments:
Experimental - A multimodal topical cream treatment with Ketoprofen, Baclofen, Amitryptiline, and lidocaine in a carrier gel. This topical formulation has been in use commercially under the trade name "Multi-profen".
Control - A identically packaged placebo cream treatment will be utilized in the control population.
Proposed duration of treatment and follow-up: Participants will be brought back at 3,6 and 12 weeks' time to complete questionnaires recording VAS and WOMAC scores
The current proposal includes 1 clinical site in Canada (Oakville Trafalgar Memorial Hospital, Oakville, ON, CAN)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Multiprofen/interventional
A multimodal topical cream treatment with Ketoprofen, Baclofen, Amitryptiline, and lidocaine in a carrier gel. This topical formulation has been in use commercially under the trade name "Multi-profen". This topical cream will be applied by the patient three times per day.
Multiprofen
A multimodal topical cream treatment with Ketoprofen, Baclofen, Amitryptiline, and lidocaine in a carrier gel.
Control/Placebo Group
A identically packaged placebo cream treatment will be utilized in the control population.
Placebo
An identically packaged placebo cream
Interventions
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Multiprofen
A multimodal topical cream treatment with Ketoprofen, Baclofen, Amitryptiline, and lidocaine in a carrier gel.
Placebo
An identically packaged placebo cream
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of symptomatic osteoarthritis of the knee based on clinical and radiographic criteria;
3. provision of informed consent.
Exclusion Criteria
2. open wounds or sores over the knee joint;
3. patients that will likely have problems, in the judgment of the investigators, with maintaining follow-up;
4. Cases involving litigation.
50 Years
80 Years
ALL
Yes
Sponsors
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McMaster University
OTHER
Oakville Trafalgar Memorial Hospital
UNKNOWN
University of Michigan
OTHER
Responsible Party
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Neil Bakshi
Researcher
Principal Investigators
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Moin Khan, MD
Role: PRINCIPAL_INVESTIGATOR
MCMASTER
Locations
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Oakville Trafalgar Memorial Hospital
Oakville, Ontario, Canada
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2017/02
Identifier Type: -
Identifier Source: org_study_id
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