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      Efficient assessment of efficacy in post-traumatic peripheral neuropathic pain patients: pregabalin in a randomized, placebo-controlled, crossover study

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          Abstract

          Background:

          Detecting the efficacy of novel analgesic agents in neuropathic pain is challenging. There is a critical need for study designs with the desirable characteristics of assay sensitivity, low placebo response, reliable pain recordings, low cost, short duration of exposure to test drug and placebo, and relevant and recruitable population.

          Methods:

          We designed a proof-of-concept, double-blind, randomized, placebo-controlled, crossover study in patients with post-traumatic peripheral neuropathic pain (PTNP) to evaluate whether such a study design had the potential to detect efficacious agents. Pregabalin, known to be efficacious in neuropathic pain, was used as the active analgesic. We also assessed physical activity throughout the study.

          Results:

          Twenty-five adults (20–70 years of age) with PTNP for ≥3 months entered a screening week and were then randomized to one of the two following treatment sequences: (1) pregabalin followed by placebo or (2) placebo followed by pregabalin. These 2-week treatment periods were separated by a 2-week washout period. Patients on pregabalin treatment received escalating doses to a final dosage of 300 mg/day (days 5–15). In an attempt to minimize placebo response, patients received placebo treatment during the screening week and the 2-week washout period. Average daily pain scores (primary endpoint) were significantly reduced for pregabalin versus placebo, with a mean treatment difference of −0.81 (95% confidence interval: −1.45 to −0.17; P = 0.015).

          Conclusion:

          The efficacy of pregabalin was similar to that identified in a large, parallel group trial in PTNP. Therefore, this efficient crossover study design has potential utility for future proof-of-concept studies in neuropathic pain.

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          Author and article information

          Journal
          J Pain Res
          J Pain Res
          Journal of Pain Research
          Dove Medical Press
          1178-7090
          2012
          27 July 2012
          : 5
          : 243-250
          Affiliations
          Clinical Research, Pfizer Worldwide Research and Development, Sandwich, Kent, UK
          Author notes
          Correspondence: Keith KC Tan, MedImmune Limited, Milstein Building, Granta Park, Cambridge CB21 6GH, UK, Tel +44 1223 898198, Fax +44 1223 471472, Email tank@ 123456medimmune.com
          Article
          jpr-5-243
          10.2147/JPR.S34098
          3413398
          22888270
          © 2012 Jenkins et al, publisher and licensee Dove Medical Press Ltd.

          This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.

          Categories
          Original Research

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