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Analysis of Analgesic Trials

In: Applied Statistics in the Pharmaceutical Industry

Author

Listed:
  • Ene I. Ette

    (Vertex Pharmaceuticals, Inc.)

  • Peter Lockwood

    (Pfizer Global Research and Development)

  • Raymond Miller

    (Pfizer Global Research and Development)

  • Jaap Mandema

    (Pharsight Corporation)

Abstract

Analgesic clinical trials are usually complex. Because of the complexity of these trials knowledge of pharmacokinetic/pharmacodynamic relationships of analgesics is limited. The consequence of this is that some recommended analgesic doses may not be optimal. The design of an analgesic clinical trial is usually of the following pattern; patients receive a single dose of an analgesic or a placebo after a pain-initiating event such as surgery, and pain intensity or pain relief is measured to assess drug efficacy at specific times after drug administration. On ethical grounds, the patients can demand a rescue medication of a known effective analgesic at any time if their pain relief is inadequate. Pain relief and remedication time—two clinical efficacy endpoints—are compared between placebo and the administered active doses of the analgesic tested.

Suggested Citation

  • Ene I. Ette & Peter Lockwood & Raymond Miller & Jaap Mandema, 2001. "Analysis of Analgesic Trials," Springer Books, in: Steven P. Millard & Andreas Krause (ed.), Applied Statistics in the Pharmaceutical Industry, chapter 10, pages 237-266, Springer.
    • Handle: RePEc:spr:sprchp:978-1-4757-3466-9_10
    DOI: 10.1007/978-1-4757-3466-9_10
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