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

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ClinicalTrials.gov Identifier: NCT03199417
Recruitment Status : Terminated (Terminated prematurely due to feasibility issues with rate of recruitment)
First Posted : June 26, 2017
Last Update Posted : March 20, 2019
Sponsor:
Collaborators:
McMaster University
Oakville Trafalgar Memorial Hospital
Information provided by (Responsible Party):
Neil Bakshi, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Multiprofen Other: Placebo Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single center blinded randomized controlled trial with a random number generator determining the allocation of patients to either the placebo or intervention groups.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Trial Evaluating multimOdal toPical Cream In CompArison to pLacebo (TOPICAL)
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199417


Locations
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Canada, Ontario
Oakville Trafalgar Memorial Hospital
Oakville, Ontario, Canada, L6M 0L8
Sponsors and Collaborators
University of Michigan
McMaster University
Oakville Trafalgar Memorial Hospital
Investigators
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Principal Investigator: Moin Khan, MD MCMASTER

Publications of Results:
Other Publications:

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Responsible Party: Neil Bakshi, Researcher, University of Michigan
ClinicalTrials.gov Identifier: NCT03199417     History of Changes
Other Study ID Numbers: 2017/02
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Ketoprofen
Amitriptyline
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Adrenergic Agents
Neurotransmitter Agents