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

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Neil Bakshi, University of Michigan
Sponsor:
Collaborators:
McMaster University
Oakville Trafalgar Memorial Hospital
Information provided by (Responsible Party):
Neil Bakshi, University of Michigan
ClinicalTrials.gov Identifier:
NCT03199417
First received: June 21, 2017
Last updated: June 23, 2017
Last verified: June 2017
  Purpose
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 Intervention Phase
Knee Osteoarthritis Drug: Multiprofen Other: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: 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: 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)

Resource links provided by NLM:


Further study details as provided by Neil Bakshi, University of Michigan:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.


Estimated Enrollment: 186
Actual Study Start Date: May 1, 2017
Estimated Study Completion Date: June 1, 2018
Estimated Primary Completion Date: December 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03199417

Contacts
Contact: Neil Bakshi, MD 7346376481 neilbaks@med.umich.edu
Contact: Moin Khan, MD 7346607601 moinkhanmd@gmail.com

Locations
Canada, Ontario
Oakville Trafalgar Memorial Hospital Recruiting
Oakville, Ontario, Canada, L6M 0L8
Contact: Moin Khan, MD    7346607601    moinkhanmd@gmail.com   
Sponsors and Collaborators
University of Michigan
McMaster University
Oakville Trafalgar Memorial Hospital
Investigators
Principal Investigator: Moin Khan, MD MCMASTER
  More Information

Publications:

Responsible Party: Neil Bakshi, Researcher, University of Michigan
ClinicalTrials.gov Identifier: NCT03199417     History of Changes
Other Study ID Numbers: 2017/02
Study First Received: June 21, 2017
Last Updated: June 23, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on June 26, 2017