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

• Drug: pregabalin and celecoxib
  

  During the first study period subjects in Arm A will be administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg BID) for one week (during Week 0) followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks. During the second study period all subjects will be administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Subjects in Arm B will be initiated on pregabalin 150 mg (75 mg BID) daily for one week, before pregabalin will up titrated to 300 mg (150 mg BID) daily.

  All subjects will complete a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose will be decreased to 150 mg (75 mg BID) daily and subjects will participate in a follow up visit for a final safety assessment.

• Drug: Placebo and celecoxib
  

  Subjects in Arm B will be administered a daily fixed dose celecoxib 200 mg and placebo of pregabalin for 5 weeks. During the second study period all subjects will be administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Subjects in Arm B will be initiated on pregabalin 150 mg (75 mg BID) daily for one week, before pregabalin will up titrated to 300 mg (150 mg BID) daily.

  All subjects will complete a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose will be decreased to 150 mg (75 mg BID) daily and subjects will participate in a follow up visit for a final safety assessment.

• Experimental: Arm A
  
  The group of patients who are randomized to receive concomitant treatment of pregabalin and celecoxib during the first study period.
  Intervention: Drug: pregabalin and celecoxib
• Arm B
  
  The group of patients who are randomized to receive celecoxib monotherapy during the first study period.
  Intervention: Drug: Placebo 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