Comparison of Increasing Doses of Tapentadol Versus a Combination of Tapentadol and Pregabalin
Condition: Low Back Pain; Neuropathic Pain
MeSH terms: Neuralgia; Back Pain; Low Back Pain
Intervention: Tapentadol Prolonged Release; Tapentadol Prolonged Release with Pregabalin; Tapentadol Prolonged Release open label maintenance
Intervention description: 100 - 500 mg per day orally twice daily for a maximum of 12 weeks; Tapentadol Prolonged Release 100 - 300 mg per day with Pregabalin 150 - 300 mg per day orally twice daily for a maximum of 12 weeks; 100 - 400 mg per day Tapentadol Prolonged Release orally administered twice daily
Intervention MeSH terms: Pregabalin; Tapentadol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 622.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: low back pain; neuropathic; pain assessment; centrally acting tapentadol pregabalin; severe chronic

Summary:

      The main objective of the study is to evaluate the effectiveness, safety, and tolerability of
      increasing doses of tapentadol prolonged release (PR) (500 mg per day) versus a combination
      of tapentadol PR (300 mg per day) and pregabalin (to 300 mg per day) in subjects requiring
      additional analgesia after titration to tapentadol PR 300 mg per day.

      This is a clinical effectiveness trial designed to establish a link between anticipated
      clinical outcomes and the clinical practice by means of selected measures of clinical and
      subject reported outcomes. Since, severe low back pain with a neuropathic component, the
      targeted study population, is frequently treated with a combination therapy (monotherapy is
      often not effective enough) it is of interest to determine if tapentadol alone (combining 2
      mechanisms of action in a single molecule) could be as effective as a combination of
      tapentadol plus pregabalin. Furthermore, the tolerability profiles of monotherapy versus
      combination are of interest.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have a diagnosis of chronic low back pain; chronic pain defined as pain
             lasting for at least 3 months.

          -  Subject's pain must require a strong analgesic (defined as World Health Organization
             (WHO) step III) as judged by the investigator.

          -  The painDETECT diagnostic screening questionnaire score must be:

               -  "positive" or

               -  "unclear".or If the subject is being treated with a stable regimen of centrally
                  acting analgesics (opioids) and/or co-analgesics, even a "negative" painDETECT
                  score (but of at least 9) at the enrollment visit will be acceptable.

          -  If under regular daily pretreatment with a WHO step II/step III opioid analgesic
             and/or a centrally acting co-analgesic:

               -  Subjects must be taking a WHO step II or step III analgesic or co- analgesic on a
                  daily basis for at least 2 weeks prior to the enrollment visit.

               -  Subjects pretreated with a WHO step II opioid analgesic and/or a centrally acting
                  co-analgesic must have reported an average pain intensity score of at least 5
                  points (NRS-3≥5) during the last 3 days prior to the enrollment visit. or If
                  under regular, daily pretreatment with a WHO step I analgesic monotherapy or if
                  no regular analgesic pretreatment is reported:

               -  Subjects must have an average pain intensity score of at least 6 points NRS-3≥6)
                  in the last 3 days prior to the enrollment visit.

        Exclusion Criteria:

          -  Presence of concomitant painful conditions other than low back pain that could
             confound the subject's trial assessments or self-evaluation of the index pain, e.g.,
             syndromes with widespread pain such as fibromyalgia.

          -  Low back pain caused by cancer and/or metastatic diseases.

          -  Any painful procedures planned during the trial period (e.g., major surgery) that may,
             in the opinion of the investigator, affect the effectiveness or safety assessments of
             the Investigational Medicinal Product (IMP).

          -  Pending litigation or application for insurance/governmental benefits due to chronic
             pain or disability and, if granted, benefits might be influenced by a successful
             participation in the trial.

          -  Rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or
             glucose-galactose malabsorption, lactose intolerance.