Experience and Challenges Presented by a Multicenter Crossover Study of Combination Analgesic Therapy for the Treatment of Painful HIV‐Associated Polyneuropathies. Issue 7 (8th April 2013)

• Record Type: Journal Article
• Authors: Harrison, Taylor; Miyahara, Sachiko; Lee, Anthony; Evans, Scott; Bastow, Barbara; Simpson, David; Gilron, Ian; Dworkin, Robert; Daar, Eric S.; Wieclaw, Linda; Clifford, David B.
• Is Part Of: Pain medicine. Volume 14:Issue 7(2013)
• Page Start: 1039
• Page End: 1047
• Publication Date: 2013-04-08
• Subjects: Pain -- Periodicals; Pain -- Treatment -- Periodicals; Analgesics -- Periodicals; Pain -- Periodicals; Pain Management -- Periodicals; Douleur -- Périodiques; Douleur -- Traitement -- Périodiques; Analgésiques -- Périodiques; Analgésique; Soulagement de la douleur; Périodique électronique (Descripteur de forme); Ressource Internet (Descripteur de forme); 616.047205
• DOI: 10.1111/pme.12084
• Languages: English
• ISSNs: 1526-2375

Abstract

<abstract abstract-type="main"> <title>Abstract</title> <sec id="pme12084-sec-0001" sec-type="section"> <title>Objective</title> <p>There is limited evidence for efficacy of analgesics as monotherapy for neuropathic pain associated with HIV‐associated polyneuropathies, in spite of demonstrated efficacy in other neuropathic pain conditions. We evaluated the tolerability and analgesic efficacy of duloxetine, methadone, and the combination of duloxetine‐methadone compared with placebo.</p> </sec> <sec id="pme12084-sec-0002" sec-type="section"> <title>Design</title> <p>This study was a phase II, randomized, double‐blind, placebo‐controlled, four‐period crossover multicenter study of analgesic therapy for patients with at least moderate neuropathic pain due to HIV‐associated polyneuropathy. Duloxetine, methadone, combination duloxetine‐methadone, and placebo were administered in four different possible sequences. The primary outcome measure was mean pain intensity (MPI) measured daily in a study‐supplied pain diary.</p> </sec> <sec id="pme12084-sec-0003" sec-type="section"> <title>Results</title> <p>A total of 15 patients were enrolled from eight study sites and eight patients completed the entire trial. Study treatments failed to show statistically significant change in MPI compared with placebo. Adverse events were frequent and associated with high rates of drug discontinuation and study dropout.</p> </sec> <sec id="pme12084-sec-0004" sec-type="section"> <title>Conclusions</title> <p>Challenges with participant recruitment and poor retention precluded trial completion to its planned targets, limiting our evaluation of the analgesic efficacy of the study treatments. Challenges to successful completion of this study and lessons learned are discussed.</p> </sec> </abstract>