International Trial of Duloxetine (Cymbalta) for Chronic Low Back Pain Is Recruiting

The purpose of this 12-week Phase III placebo-controlled study is to determine if duloxetine (Cymbalta®) reduces the severity of chronic low back pain.

The 26 trial centers are located in 7 countries – the U.S., Brazil, Germany, the Netherlands, Poland, Russian Federation, and Spain. Patients who have used duloxetine in the past or who currently use narcotics daily will not be eligible. Target enrollment is 400 patients.

Duloxetine is a serotonin-norepinephrine reuptake inhibitor (SNRI) whose main applications to date are in major depressive disorder, general anxiety disorder, stress urinary incontinence, and painful peripheral neuropathy. In June 2008, duloxetine also became the second drug to win FDA approved for treatment of fibromyalgia in the US, though approval was declined recently in the EU. (Notably, chronic low back pain affects as many as 63% of fibromyalgia patients, according to an online survey conducted by the National Fibromyalgia Association.)

For more information – including the locations of participating trial centers and to contact the trial organizers with any questions – go to the ClinicalTrials.gov listing for this study, at http://clinicaltrials.gov/ct2/show/NCT00767806

1 Star2 Stars3 Stars4 Stars5 Stars (No Ratings Yet)
Loading...



3 thoughts on “International Trial of Duloxetine (Cymbalta) for Chronic Low Back Pain Is Recruiting”

  1. toots2 says:

    I wanted to add comments as a user of cymbalta, which works well for me as an antidepressant although it took a while for it to kick in. While everyone is different, my initial experience with cymbalta was great in that I was almost completely out of pain for about three months. I never felt better. However, as with many medications, I apparently became immune to the pain reliever in cymbalta as after that initial three months, my pain returned. I still use it and would recommend it to others. I just wish the pain relief had lasted indefinitely but then again figure that is way too much to expect. For pain other than chronic pain, cymbalta should help a lot of people. Thanks.

  2. meedmo42 says:

    The comment on the length of help of this medication sounds normal. I have been taking generic Soma for many years, interspersed with vicoprofen when the pain gets worse. I am amazed and pleased that since I regulate it only to disabling pain from my Fibro (in the back), it has continued to work for many years. I dread the day when it does not work any longer, but just take each day at a time. I think the Vico also works much like an antidepressent as I relax and the pain disappears and I feel like a healthy person for awhile. Since it is so very welcome, I keep a journal and limit my use of the pill to only the really painful episodes when I know a muscle spasm is going to happen if I don’t take something. I may have days of no vico, and then have a stressful day when I take 1-3 during the day. Fibro is a disease everyone has to work with on their own. Glad that Cymbalta works for some. (BTW, Lyrica just made me “out of it” with no help in the pain.)

    Mary E.
    Goshen, IN

  3. ttu says:

    I tried Cymbalta but couldn’t get past the extreme nausea each time I took it. My doctor was hoping it would help my fibro pain. I got so nauseated that I couldn’t raise my head off the bed. I am diabetic plus I have had fibromyalgia since I was diagnosed with Stevens-Johnson Syndrome in 1998 and suffer greatly, especially if I house clean,do yard work,etc. I also have severe lower back and neck pain with bulging and herniated discs in both areas. With allergies/reactions to lots of pain medications,I haven’t found anything to really control the pain. About 3 mos ago, I started taking Vitamin D, 50,000 units, 1 @ week, and I think it has helped my fibro pain a bit. My pain doctor started me on Lyrica 50 mg several months ago, then gave me 125 mg, but my feet, ankles and legs swelled so bad that I couldn’t walk and was a zombie, so I had to go back to 50 mg-1 daily. I still have blurred vision even with Lyrica 50. I keep hoping and praying that soon some medication will come out that will help reduce my pain, even 50% would be wonderful. I haven’t have the courage to try Cymbalta again.

Leave a Reply