Efficacy and Safety Study of Celecoxib and Pregabalin Compared With Celecoxib Monotherapy, in Patients With Chronic Low Back Pain Having a Neuropathic Component
Condition: Chronic Low Back Pain With a Neuropathic Component
MeSH terms: Back Pain; Low Back Pain
Intervention: pregabalin and celecoxib; Placebo and celecoxib
Intervention description: 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.; 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.
Intervention MeSH terms: Celecoxib; Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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