Analysis of Analgesic Trials

Ene I. Ette, Peter Lockwood, Raymond Miller and Jaap Mandema
Additional contact information
Ene I. Ette: Vertex Pharmaceuticals, Inc.
Peter Lockwood: Pfizer Global Research and Development
Raymond Miller: Pfizer Global Research and Development
Jaap Mandema: Pharsight Corporation

Chapter 10 in Applied Statistics in the Pharmaceutical Industry, 2001, pp 237-266 from Springer

Abstract: 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.

Keywords: Pain Relief; Modify Release; Nonlinear Mixed Effect; Population Pharmacokinetic Parameter; Adequate Pain Relief (search for similar items in EconPapers)
Date: 2001
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DOI: 10.1007/978-1-4757-3466-9_10

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