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In this phase III study, 981 patients with moderate-to-severe chronic low back pain were randomized to receive controlled adjustable doses of tapentadol ER (100-250mg), oxycodone HCl CR (20-50mg), or placebo bid for 12 weeks following a 3-week titration period; 965 patients were evaluable for safety and 958 for efficacy. Both tapentadol ER and oxycodone CR significantly (P < 0.001 for both) reduced pain intensity compared with placebo at Week 12 using the last observation carried forward for missing values.

Efficacy and safety of tapentadol ER for chronic low back pain: results of a randomized, double-blind, placebo-and active-controlled phase III study

Authors » R Buynak, D Shapiro, A Okamoto, I Van Hove, M Etropolski

Journal » The Journal of Pain

Year » 2009

This article is included in 1 Systematic review Systematic reviews (1 reference)

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Dose stability of tapentadol ER for the relief of chronic low back pain: results of a randomized, active- and placebo-controlled study.

Authors » Buynak R, Etropolski M, Lange B, Shapiro D, Douglas Y, Okamoto A, et al.

Journal » Arthritis and Rheumatism

Year » 2009

This article is included in 1 Systematic review Systematic reviews (1 reference)

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Efficacy and safety of tapentadol extended release for the management of chronic low back pain: Results of a prospective, randomized, double-blind, placebo- and active-controlled Phase III study

Authors » Buynak R , Shapiro DY , Okamoto A , Van Hove I , Rauschkolb C , Steup A , Lange B , Lange C , Etropolski M

Journal » Expert opinion on pharmacotherapy

Year » 2010

Links » Pubmed DOI

This article is included in 12 Systematic reviews Systematic reviews (12 references)

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Objective: To evaluate the efficacy and safety of tapentadol extended release (ER) for the management of moderate to severe chronic low back pain. Research design: Patients (N 981) were randomized 1:1:1 to receive tapentadol ER 100 250 mg b.i.d., oxycodone HCl controlled release (CR) 20 50 mg b.i.d., or placebo over 15 weeks (3-week titration period, 12-week maintenance period). Main outcome measures: Efficacy was assessed as change from baseline in average pain intensity (11-point NRS) at week 12 of the maintenance period and throughout the maintenance period; last observation carried forward was used to impute missing pain scores. Adverse events (AEs) were monitored throughout the study. Results: Tapentadol ER significantly reduced average pain intensity versus placebo at week 12 (least squares mean difference vs placebo [95% confidence interval], -0.8 [-1.22, -0.47]; p < 0.001) and throughout the maintenance period (-0.7 [-1.06,-0.35]; p < 0.001). Oxycodone CR significantly reduced average pain intensity versus placebo at week 12 (-0.9 [-1.24,-0.49]; p < 0.001) and throughout the maintenance period (-0.8 [-1.16,-0.46]; p < 0.001). Tapentadol ER was associated with a lower incidence of treatment-emergent AEs (TEAEs) than oxycodone CR. Gastrointestinal TEAEs, including constipation, nausea, and vomiting, were among the most commonly reported TEAEs (placebo, 26.3%; tapentadol ER, 43.7%; oxycodone CR, 61.9%). The odds of experiencing constipation or the composite of nausea and/or vomiting were significantly lower with tapentadol ER than with oxycodone CR (both p < 0.001). Conclusions: Tapentadol ER (100 250 mg b.i.d.) effectively relieved moderate to severe chronic low back pain over 15 weeks and had better gastrointestinal tolerability than oxycodone HCl CR (20 50 mg b.i.d.). © 2010 Informa UK Ltd.

Erratum: efficacy and safety of tapentadol extended release for the management of chronic low back pain: results of a prospective, randomized, double-blind, placebo- and active-controlled Phase III study (Expert Opinion on Pharmacotherapy (2010) 11(11): 1

Authors » Buynak R, Shapiro DY, Okamoto A, Van Hove I, Rauschkolb C, Steup A, et al.

Journal » Expert Opinion on Pharmacotherapy

Year » 2010

This article is not included in any systematic review

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RESULTS OF A RANDOMIZED, DOUBLE-BLIND, PLACEBO-AND ACTIVE-CONTROLLED TRIAL OF TAPENTADOL EXTENDED RELEASE FOR CHRONIC LOW BACK PAIN

Authors » Douglas Shapiro, Robert Buynak, Akiko Okamoto, Ilse Van Hove, Achim Steup, Bernd Lange, Thomas Haufel, Mila Etropolski

Journal » Rheumatology

Year » 2010

This article is included in 1 Systematic review Systematic reviews (1 reference)

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