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