IngentaConnect Open-label study of the safety and effectiveness of long-term the...

Authors: Pascual, Maria Luz G.¹; Fleming, Rosa Rosanna B.¹; Gana, Theophilus J.²; Vorsanger, Gary J.³

Source: Current Medical Research and Opinion, Volume 23, Number 10, October 2007 , pp. 2531-2542(12)

Abstract:

Background: Tramadol ER is a once-daily oral analgesic for management of moderate-to-moderately severe chronic pain in adults who require around-the-clock treatment of pain. This study evaluated long-term safety of tramadol ER and effectiveness outcomes in the management of chronic, nonmalignant pain.

Methods: Patients enrolled directly for approximately 1 year of open-label tramadol ER treatment if they had chronic, nonmalignant pain (n = 919), or 'rolled over' for 38 weeks of open-label tramadol ER treatment if they completed either of two 12-week, placebo-controlled studies of tramadol ER for low back pain (n = 72) or osteoarthritis (n = 61). Tramadol ER was titrated to a dose of 300 mg once daily (patients ≥ 75 years) or 300-400 mg once daily (patients < 75 years).

Results: A total of 257 (24%) patients completed the study. Common adverse events, regardless of treatment relationship, were nausea, dizziness (excluding vertigo), and constipation. Mean scores for current pain intensity (from 0 = no pain to 100 = extreme pain) and least, worst, and average pain intensity over the past week improved at every post-baseline visit. At each post-baseline visit, > 50% of patients provided a global assessment rating of good, very good, or excellent. Study limitations were mandatory titration to 400 mg in some patients, concomitant analgesic therapy as a confounding variable, and lack of a placebo comparator.

Conclusions: Individualized dose titration and limiting once-daily therapy with tramadol ER to the maximum recommended daily dose of 300 mg may balance tolerability and analgesic effects of tramadol ER in patients with chronic, nonmalignant pain.

Keywords: CHRONIC PAIN; EXTENDED-RELEASE; LOW BACK PAIN; NONMALIGNANT PAIN; OSTEOARTHRITIS; TRAMADOL

Document Type: Research article

DOI: 10.1185/030079907X233179

Affiliations: 1: Clinical Development, Biovail Technologies, Ltd., Bridgewater, NJ, USA 2: Biopharmatech Consulting, Inc., Leesburg, VA, USA 3: Medical Affairs, Ortho-McNeil Janssen Scientific Affairs, LLC, Raritan, NJ, USA

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Open-label study of the safety and effectiveness of long-term therapy with extended-release tramadol in the management of chronic nonmalignant pain