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Efficacy and Safety of Controlled-Release Versus Immediate-Release Oxycodone: Randomized, Double-Blind Evaluation in Patients with Chronic Back Pain

Hale, Martin E. M.D.; Fleischmann, Roy M.D.*; Salzman, Robert M.D.; Wild, James M.D.; Iwan, Tad B.A.§; Swanton, Ruth E. M.P.H.§; Kaiko, Robert F. Ph.D.§; Lacouture, Peter G. Ph.D.§

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Objective: To compare the efficacy and safety of controlled-release oxycodone given every 12 hours with immediate-release oxycodone given four times daily in patients with persistent back pain.

Design: Randomized, double-blind, active-controlled, two-period crossover trial.

Patients: Fifty-seven adult outpatients with stable, chronic, moderate-to-severe low back pain despite analgesic therapy were enrolled; 47 were randomized; 11 discontinued for side effects, most commonly nausea and vomiting.

Interventions: Controlled-release oxycodone tablets given every 12 hours; immediate-release oxycodone tablets given four times daily; dose titration with controlled-release or immediate-release for up to 10 days; double-blind treatment for 4-7 days each.

Outcome Measures: Patients' pain scores (0 = none, 1 = slight, 2 = moderate, 3 = severe).

Results: Pain intensity decreased from moderate to severe at baseline to slight at the end of titration with both oxycodone formulations. The daily oxycodone dose was 40 mg or less in 68% of patients. During double-blind treatment, mean pain intensity was maintained at 1.2 (0.1 SE) with controlled-release and at 1.1 (0.1 SE) with immediate-release oxycodone. The most common adverse events were constipation, nausea, pruritus, somnolence, and dizziness.

Conclusions: Controlled-release oxycodone given every 12 hours was comparable with immediate-release oxycodone given four times daily in efficacy and safety, and it provides convenient, twice-daily, around-the-clock treatment for selected patients with persistent back pain that is inadequately controlled by nonopioids or as-needed opioid therapy.

Park Place Therapeutic Center, Plantation, Florida; *Metroplex Clinical Research Center, Dallas, Texas; †Miami Research Associates, Miami, Florida; ‡Private Practice in Rheumatology, San Antonio, Texas; §Medical Department, Purdue Pharma L.P., Norwalk, Connecticut, U.S.A.

Manuscript submitted April 21, 1998; first revision received December 8, 1998; second revision received March 23, 1999; accepted for publication June 28, 1999.

Address correspondence and reprint requests to Dr. Martin E. Hale, Park Place Therapeutic Center, 301 N.W. 84th Avenue, Suite 304, Plantation, FL 33324 U.S.A.

© 1999 Lippincott Williams & Wilkins, Inc.