Milnacipran for Chronic Pain in Knee Osteoarthritis (KOA)
The patients are asked to take part in this study because you have chronic pain as a result of knee osteoarthritis. This study is done to investigate the pain relieving effects of the study drug Savella (milnacipran HCl) for people who experience chronic osteoarthritis pain. The purpose of this research is to look at how the study drug can be used to benefit people who experience osteoarthritis knee pain. This is a phase IV study done to study the safety and effectiveness of the drug. At this point the drug is already approved by the Food and Drug Administration for people with fibromyalgia but it has not yet been approved for people with knee osteoarthritis.
Degenerative Joint Disease
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Milnacipran for the Pain, Sensory Sensitization and Mood Changes in Knee Osteoarthritis|
- The efficacy of Milnacipran (Savella), measured by the change of knee pain, in treating chronic knee osteoarthritis pain. [ Time Frame: 3 visits over 11 weeks: Visit 1 (week 1), Visit 2 (week 2) and Visit 3 (Week 9). In addition, we will have electronic diary entries with pain, fatigue and functioning scores three times a day for 79 days. ] [ Designated as safety issue: No ]Intent to treat analyses will compare data from the groups for all participants with at least two data points. A series of mixed design ANOVAs will be completed with data from objective functional testing, quasi-objective functional and psychophysical testing, subject pain questionnaires and subjective perceived function and quality of life.
- Change of physical functional ability due to change in knee pain [ Time Frame: 3 visits over 11 weeks: Visit 1 (week 1), Visit 2 (week 2) and Visit 3 (Week 9). In addition, we will have electronic diary entries with pain, fatigue and functioning scores three times a day for 79 days. ] [ Designated as safety issue: No ]A second set of follow-up analyses will test for nonlinear patterns of change over time. It is expected that some outcome factors will show quadratic trends such that, for instance, activity level will change depending on pain ratings.
|Study Start Date:||November 2010|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Sugar Pill||
Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
Other Name: Savella (milnacipran HCL) Tablets
If you are in this study, you will be placed in one of two study groups: one group will receive the study drug and one will receive a placebo. You will be assigned a study group by chance using a process similar to the flip of a coin.
At the first visit (week one) we will review and sign the informed consent, obtain your medical health history, and conduct a brief physical exam. You will also complete several questionnaires about your pain. You will be assessed for your eligibility to participate in this study. If you are eligible, we will conduct some physical and sensory tests and collect a blood sample. The physical tests include a stair climb, 6-minute treadmill test and a 1-minute sit to stand test. The sensory tests allow us to understand your perception of various stimuli such as vibration, light touch, pinprick, heat, cold, hot pain, and cold pain. At the end of the first visit you will be given an electronic diary to record your pain throughout the study. We will also ask you to wear a device in a T-shirt, similar to an accelerometer, that will be used to record your sleep quality and physical activity for 2 days.
At the second (week two) and third visits (week nine) you will be asked to complete the same questionnaires, physical and sensory tests as during the first visit. You will also have to wear the t-shirt with the device for 2 days after each visit.
|United States, Illinois|
|Rehabilitation Institute of Chicago, Center for Pain Studies|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Norman Harden, MD||Center for Pain Studies, Rehabilitation Institute of Chicago|