Milnacipran for Chronic Pain in Knee Osteoarthritis

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Norman Harden
• Collaborator: Forest Laboratories
• Treatments: Levomilnacipran; Milnacipran

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)