Trial Evaluating multimOdal toPical Cream In CompArison to pLacebo (TOPICAL)

NCT03199417 | Terminated Phase 2 DMC

• 1 other identifier: 2017/02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change in pain visual analog scale (VAS) scores (0-10) from baseline

  Measurement of change in patient reported pain score (VAS) at various follow up appointments. The scale is from 0-10, with 10 being the most pain.

  week 0, week 3, week 6, week 12

Secondary Outcomes (2)

• Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores from baseline

  week 0, week 3, week 6, week 12

• Change in Range of motion (ROM) from baseline

  week 0, week 3, week 6, week 12

Study Arms (2)

Multiprofen/interventional

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". This topical cream will be applied by the patient three times per day.

Drug: Multiprofen

Control/Placebo Group

PLACEBO COMPARATOR

A identically packaged placebo cream treatment will be utilized in the control population.

Other: Placebo

Interventions

Multiprofen DRUG

A multimodal topical cream treatment with Ketoprofen, Baclofen, Amitryptiline, and lidocaine in a carrier gel.

Multiprofen/interventional

Placebo OTHER

An identically packaged placebo cream

Control/Placebo Group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult men or women ages 50-80 years;
• Diagnosis of symptomatic osteoarthritis of the knee based on clinical and radiographic criteria;
• provision of informed consent.

You may not qualify if:

• patients with inflammatory osteoarthritis;
• open wounds or sores over the knee joint;
• patients that will likely have problems, in the judgment of the investigators, with maintaining follow-up;
• Cases involving litigation.

Sponsors & Collaborators

• University of Michigan: lead
• McMaster University: collaborator
• Oakville Trafalgar Memorial Hospital: collaborator

Study Sites (1)

Oakville Trafalgar Memorial Hospital

Oakville, Ontario, L6M 0L8, Canada

Location

Related Publications (8)

• 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.

  PMID: 22081470 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.

  PMID: 26806189 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.

  PMID: 24547601 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.

  PMID: 23374622 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.

  PMID: 22402677 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.

  PMID: 25645576 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.

  PMID: 27125590 BACKGROUND

• 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.

  PMID: 18565256 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Moin Khan, MD

  MCMASTER

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will be randomized using a random number generator to either intervention. Interventions will be identically packaged and labeled either A or B by a pharmacist who will be uninvolved with the trial administration. Participants and study personnel will be blinded to the treatment groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: Single center blinded randomized controlled trial with a random number generator determining the allocation of patients to either the placebo or intervention groups.

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: June 26, 2017
• Study Start: May 1, 2017
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: March 20, 2019

Record last verified: 2019-03

Locations

CA (1)