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      Effectiveness and safety of morphine sulfate extended-release capsules in patients with chronic, moderate-to-severe pain in a primary care setting

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          The purpose of this study was to determine the effectiveness and safety of morphine sulfate extended-release capsules among primary care patients with chronic, moderate-to-severe pain using a universal precautions approach that assessed and monitored risk for opioid misuse and abuse.


          This open-label, uncontrolled, multicenter, prospective study was conducted in primary care centers (n = 281) and included opioid-naïve and opioid-experienced patients with either a pain score ≥4 (0 = no pain, 10 = pain as bad as you can imagine), or with unacceptable side effects while taking opioids. The patients were treated with morphine sulfate extendedrelease capsules for up to four months. Patient-rated pain intensity (worst, least, average) over the past 24 hours (0–10 scale), pain interference with seven activities of daily living (0 = no interference, 10 = completely interferes), and adverse events were recorded.


          Of 1487 patients who filled at least one prescription, 561 (38%) completed the study. Patients were primarily white (87%) and female (57%); 92% had pain for more than one year; and 79% were opioid-experienced. Median age was 52 years. Decreases in mean (± standard deviation) average pain scores (baseline 6.2 ± 2.3) were −0.8 ± 2.2 at visit 2 (5–14 days later), and −1.6 ± 2.3 and −1.7 ± 2.2 at visits 3 and 4 (spaced 3–4 weeks apart), respectively, and −1.1 ± 2.4 at visit 5 (included patients withdrawn from the study who were no longer taking the study drug). A similar trend was observed for worst pain and least pain scores and for pain interference with activities. Fifty-one percent of the safety population patients and 81% in the completer population reported being satisfied or very satisfied with the study treatment. Most common adverse events were typical of opioids, ie, constipation (14%), nausea (11%), vomiting (5%), and somnolence (5%).


          The results suggest that pain outcomes improved in patients with chronic, moderate-to-severe pain receiving morphine sulfate extended-release capsules within the context of a structured universal precautions approach in the primary care setting.

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          Author and article information

          J Pain Res
          Journal of Pain Research
          Dove Medical Press
          08 November 2011
          : 4
          : 373-384
          [1 ]Jena Medical, Ormond Beach, FL
          [2 ]Pfizer Inc, Cary, NC
          [3 ]Randolph Medical Associates, Asheboro, NC
          [4 ]Archimedes Pharma US Inc, Bedminster, NJ
          [5 ]Lifetree Clinical Research, Salt Lake City, UT, USA
          Author notes
          Correspondence: Beatrice Setnik, Pfizer Inc, 4000 Centre Green Way Suite 300, Cary, NC 27513, USA Tel +1 919 653 7071, Fax +1 919 653 7022, Email beatrice.setnik@ 123456pfizer.com
          © 2011 Brown 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.

          Original Research


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