Efficacy and Safety Study of Celecoxib and Pregabalin Compared With Celecoxib Monotherapy, in Patients With Chronic Low Back Pain Having a Neuropathic Component

A Randomized Double Blind Placebo Controlled Parallel Group Study Of The Efficacy And Safety Of Concomitant Administration Of Celecoxib And Pregabalin Compared With Celecoxib Monotherapy, In Patients With Chronic Low Back Pain Having A Neuropathic Component

The purpose of this study is to determine if treatment with celecoxib and pregabalin together would prove to be more effective in relief of pain than treatment with celecoxib alone in people who have chronic low back pain with a probable neuropathic component.

The primary objective is to evaluate the efficacy of the concomitant use of pregabalin and celecoxib compared with celecoxib monotherapy for the symptomatic relief of pain in patients with chronic low back pain with a probable neuropathic component.

The secondary objectives are:

• Demonstrate the additional benefit of adding pregabalin to celecoxib monotherapy.
• To evaluate the concomitant use of pregabalin and celecoxib compared to celecoxib monotherapy in a set of patient reported measures (sleep, depression, anxiety, impact of pain in daily functions, patient's global impression of change and patient's perception of the treatment).
• To evaluate the safety and tolerability of celecoxib and of the concomitant administration of pregabalin and celecoxib.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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