- Patients must have low back pain with a neuropathic pain component between 3 months
and 12 months duration prior to entering the study.
- Patients must have a score of at least 19 on the PainDetect questionnaire and at
least 4 on the Standardized Evaluation of Pain (StEP) scale at screening.
- Patients must have a mean pain numerical rating scale (NRS) score of 4 or more during
the one week screening period.
- Patients must have failed to respond to standard analgesic therapy (e.g.
non-steroidal anti-inflammatory drugs [NSAIDs]) and/or one treatment for neuropathic
pain (e.g. tricyclics, serotonin-norepinephrine re-uptake inhibitors [SNRIs]) prior
to entering the study).
- A diagnosis of depression or a Hospital Anxiety and Depression Scale (HADS) score of
> 15 on the depression sub-scale only.
- Patients with a history of renal impairment or who have reduced renal function at
baseline (Creatinine Clearance
- Patients who have previously taken pregabalin or gabapentin within 6 months prior to
entering the study.
- Patients who have undergone previous surgery for back pain.
- Patients who are using high doses of opioid medication (morphine > 60 mg per day).