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

March 18, 2019 updated by: Neil Bakshi, University of Michigan
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Knee osteoarthritis (OA) is a disease with a high global burden, and multiple conservative treatment options are available. In addition to being a major source of disability osteoarthritis results in a significant economic burden as well. A study published in 2012 showed the 1-year physician, outpatient procedure, and hospitalization costs in patients with osteoarthritis more than double those patients without osteoarthritis in Ontario.

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)

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Oakville, Ontario, Canada, L6M 0L8
        • Oakville Trafalgar Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

The inclusion criteria are:

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

Exclusion Criteria:

The exclusion criteria are:

  1. patients with inflammatory osteoarthritis;
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Multiprofen
A multimodal topical cream treatment with Ketoprofen, Baclofen, Amitryptiline, and lidocaine in a carrier gel.
Placebo Comparator: Control/Placebo Group
A identically packaged placebo cream treatment will be utilized in the control population.
Other: Placebo
An identically packaged placebo cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain visual analog scale (VAS) scores (0-10) from baseline
Time Frame: week 0, week 3, week 6, week 12
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores from baseline
Time Frame: week 0, week 3, week 6, week 12
Change in patient reported knee pain and function scores. WOMAC score has 3 subdivisions which include knee pain, stiffness, and physical function. The score ranges from 0-96, with lower scores representing better knee pain, stiffness, and function.
week 0, week 3, week 6, week 12
Change in Range of motion (ROM) from baseline
Time Frame: week 0, week 3, week 6, week 12
Change in range of motion of the knee at various time points that will be compared to pre-treatment range of motion. Higher range of motion is correlated with better outcome and better function.
week 0, week 3, week 6, week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

McMaster University
Oakville Trafalgar Memorial Hospital

Investigators

  • Principal Investigator: Moin Khan, MD, Mcmaster

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Actual)

May 30, 2018

Study Completion (Actual)

May 30, 2018

Study Registration Dates

First Submitted

June 21, 2017

First Submitted That Met QC Criteria

June 23, 2017

First Posted (Actual)

June 26, 2017

Study Record Updates

Last Update Posted (Actual)

March 20, 2019

Last Update Submitted That Met QC Criteria

March 18, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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