@article {Pascual:October 2007:0300-7995:2531,
	author = "Pascual, Maria Luz G.",
	author = "Fleming, Rosa Rosanna B.",
	author = "Gana, Theophilus J.",
	author = "Vorsanger, Gary J.",
	title = "Open-label study of the safety and effectiveness of long-term therapy with extended-release tramadol in the management of chronic nonmalignant pain",
	journal = "Current Medical Research and Opinion",
	volume = "23",
	year = "October 2007",
	abstract = "<I>Background:</I> 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.<P></P><I>Methods:</I> Patients enrolled directly for approximately 1 year of open-label tramadol ER treatment if they had chronic, nonmalignant pain (<I>n</I> = 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 (<I>n</I> = 72) or osteoarthritis (<I>n</I> = 61). Tramadol ER was titrated to a dose of 300 mg once daily (patients &#8805; 75 years) or 300-400 mg once daily (patients &#60; 75 years).<P></P><I>Results:</I> 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, &#62; 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.<P></P><I>Conclusions:</I> 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.",
	pages = "2531-2542(12)",
	url = "http://www.ingentaconnect.com/content/apl/cmro/2007/00000023/00000010/art00024"
	doi = "doi:10.1185/030079907X233179"
}