- Subjects must have Chronic low back pain with high probability of a significant
neuropathic component for 4 years or less (but no less than 3 months)
- Subjects must be in generally good health, except for the presence of chronic low back
pain with a neuropathic component.
- Subjects must be literate and have the ability (unaided) to understand and use the
interactive voice response system (IVRS), have daily access to a telephone or the
internet in order to complete the IVRS assessments each day, perform telephone or web
visits and complete all required assessments/forms
- Subjects with past history of surgery for chronic low back pain.
- Subjects with past history of failure on pregabalin treatment and/or intolerance
associated with pregabalin or gabapentin.
- Subjects with past history of intolerance associated with celecoxib or known
hypersensitivity to celecoxib.
- Patients with anticipated need for treatment with opioid analgesics, anti-epileptic
medications, SNRI antidepressants or tricyclic antidepressants to alleviate pain
during the course of the study.
- Patients with chronic low back pain with a neuropathic component for more than 4
years.
- Patients with neurologic disorders unrelated to low back pain that may confuse or
confound the assessment of neuropathic pain (eg, primary or secondary nerve diseases).
- Subjects considered at risk of suicide or self-harm based on investigator judgment
and/or details of a risk assessment.
- Use of prohibited medications in the absence of appropriate washout periods.
- Patients with any severe pain associated with conditions other than chronic low back
pain with a neuropathic component that may confound the assessment or self-evaluation
of the pain due to chronic low back pain.
- Patients with diabetes with poor glycemic control (HbA1c >8%).
- Patients with any clinically significant or unstable medical or psychiatric condition
or laboratory abnormality that, in the opinion of the investigator, would compromise
participation in the study
- Patients who have participated in any previous clinical trial for pregabalin or have
participated in 2 or more previous clinical trials for pain related to chronic low
back pain.
- Patients who are likely to require surgery during the course of the study (except
minor surgery, eg, for skin conditions)
- Patients with a history of Substance Abuse as defined by DSM-IV-TR diagnostic criteria