Status:
COMPLETED
Milnacipran for Chronic Pain in Knee Osteoarthritis
Lead Sponsor:
Dr. Norman Harden
Collaborating Sponsors:
Forest Laboratories
Conditions:
Knee Osteoarthritis
Degenerative Joint Disease
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
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 Savel...
Detailed Description
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 proc...
Eligibility Criteria
Inclusion
- Knee pain and osteophytes on radiographs OR
- Knee pain plus patient age of 40 years or older, morning stiffness lasting 30 minutes or less, and crepitus (cracking sound) during motion
- Experiences chronic pain for 6 months or longer
- Average pain rating of worse knee is equal to 4 or greater on a 0-10 scale
- If female, is not pregnant or breast feeding, and not currently attempting to conceive; if of childbearing potential, use of a highly effective method of birth control (as determined by Pl)
- Able to walk at least ½ a city block a day, and agrees to try and slowly increase that over the course of study
- Able to read and speak English and provide informed consent
- Able to understand and comply with all data collection methodology including electronic diary
- Subject agrees to 1) continue their stable drug regimen with no changes during the course of study, 2) only use Tylenol 325 mg of tablets (a maximum of 8 tablets a day) for breakthrough pain, and 3) not use Tylenol or any other pain medicines 12 hours before testing.
Exclusion
- Subject takes SNRIs (Savella, Cymbalta, Venlafaxine) or other neuroamine re-uptake blockers for mood disorders
- Subject is allergic to SSRIs, SNRIs, or milnacipran
- Subject has severe or untreated psychiatric disturbance (e.g. mania, depression, anxiety, substance dependence)
- Subject is medicated with 'triptans, MAOIs, SSRIs, other SNRIs, tricyclic or heterocyclic antidepressants, lithium, epinephrine, norepinephrine, clonidine or digoxin during the trial
- Subject has a clinical diagnosis of fibromyalgia
- Subject has severe ongoing or unaddressed medical conditions (e.g. Renal or Hepatic disease \[creatinine\>1.5 ml/dl; AST or ALT\> 3x normal limit\], uncontrolled hypertension, severe cardiac rate or rhythm disorders, rheumatologic disease (e.g. polymyalgia rheumatica), narrow angle glaucoma, hyponatremia, clotting disorders, uncontrolled seizure disorder or urinary retention)
- Subject has cardiac implants
- Subject has a knee replacement
- Subject plans to start new pain treatments or therapies during the study (e.g. new pain medication, injections, PT, surgery)
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01510457
Start Date
November 1 2010
End Date
October 1 2013
Last Update
June 22 2015
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