Trial Evaluating multimOdal toPical Cream In CompArison to pLacebo (TOPICAL) (TOPICAL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Drug: Multiprofen Other: Placebo||Phase 2 Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|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.|
|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|
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.
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.
An identically packaged placebo cream
- 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.
- 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.
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
|Oakville Trafalgar Memorial Hospital|
|Oakville, Ontario, Canada, L6M 0L8|
|Principal Investigator:||Moin Khan, MD||MCMASTER|