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Original Article

Safety and efficacy of oxycodone/naloxone vs. oxycodone vs. morphine for the treatment of chronic low back pain: results of a 12 week prospective, randomized, open-label blinded endpoint streamlined study with prolonged-release preparations

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Pages 1413-1429 | Accepted 29 Apr 2015, Published online: 29 May 2015

Keep up to date with the latest research on this topic with citation updates for this article.

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Michael A. Ueberall, Ute Essner, Gerhard Müller-Schwefe, Johannes Horlemann & Martin Storr. (2022) Prevalence of drug-induced constipation and severity of associated biopsychosocial effects in patients with nonmalignant pain: a cross-sectional review of depersonalized data from the German Pain e-Registry. Current Medical Research and Opinion 38:1, pages 101-114.
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Filip Jovanovic, Iulia Pirvulescu, Emilija Knezevic, Kenneth D. Candido & Nebojsa Nick Knezevic. (2021) Comparative safety review of current treatment options for chronic low back pain and unmet needs: a narrative review. Expert Opinion on Drug Safety 20:9, pages 1005-1033.
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R. Freynhagen, C. Elling, T. Radic, M. Sohns, H. Liedgens, D. James, R. McCool & M. Edwards. (2021) Safety of tapentadol compared with other opioids in chronic pain treatment: network meta-analysis of randomized controlled and withdrawal trials. Current Medical Research and Opinion 37:1, pages 89-100.
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Jeffrey Gudin, Andrew G Kaufman & Samyadev Datta. (2020) Are Opioids Needed to Treat Chronic Low Back Pain? A Review of Treatment Options and Analgesics in Development. Journal of Pain Research 13, pages 1007-1022.
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Carsten Bantel, Shiva S Tripathi, David Molony, Tony Heffernan, Susmita Oomman, Vivek Mehta & Sara Dickerson. (2018) Prolonged-release oxycodone/naloxone reduces opioid-induced constipation and improves quality of life in laxative-refractory patients: results of an observational study. Clinical and Experimental Gastroenterology 11, pages 57-67.
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Joseph V Pergolizzi$suffix/text()$suffix/text(), Robert B Raffa, Marco Pappagallo, Charles Fleischer, Joseph Pergolizzi$suffix/text()$suffix/text(), Gianpietro Zampogna, Elizabeth Duval, Janan Hishmeh, Jo Ann LeQuang & Robert Taylor$suffix/text()$suffix/text(). (2017) Peripherally acting μ-opioid receptor antagonists as treatment options for constipation in noncancer pain patients on chronic opioid therapy. Patient Preference and Adherence 11, pages 107-119.
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Gineke Koopmans-Klein, Joeri Van Op den Bosch, Yvonne van Megen, Hans Prenen, Frank Huygen & Isabelle Mancini. (2017) Prolonged release oxycodone and naloxone treatment counteracts opioid-induced constipation in patients with severe pain compared to previous analgesic treatment. Current Medical Research and Opinion 33:12, pages 2217-2227.
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Stefano De Santis, Cristina Borghesi, Serena Ricciardi, Daniele Giovannoni, Alberto Fulvi, Maria Rita Migliorino & Claudio Marcassa. (2016) Analgesic effectiveness and tolerability of oral oxycodone/naloxone and pregabalin in patients with lung cancer and neuropathic pain: an observational analysis. OncoTargets and Therapy 9, pages 4043-4052.
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Emiliano Petrò, Elena Ruffini, Melania Cappuccio, Valeria Guerini, Gloria Belotti, Sara Fascendini, Cristina Licini & Claudio Marcassa. (2016) Low-dose oral prolonged-release oxycodone/naloxone for chronic pain in elderly patients with cognitive impairment: an efficacy–tolerability pilot study. Neuropsychiatric Disease and Treatment 12, pages 559-569.
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Michael A Ueberall, Alice Eberhardt & Gerhard HH Mueller-Schwefe. (2016) Quality of life under oxycodone/naloxone, oxycodone, or morphine treatment for chronic low back pain in routine clinical practice. International Journal of General Medicine 9, pages 39-51.
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Mellar P. Davis. (2016) Pharmacokinetic and pharmacodynamic evaluation of oxycodone and naltrexone for the treatment of chronic lower back pain. Expert Opinion on Drug Metabolism & Toxicology 12:7, pages 823-831.
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Takahiro Higashibata, Jun Hamano, Takaomi Kessoku, Shinya Kajiura, Mami Hirakawa, Yoshiki Horie, Masaki Shimizu, Shunsuke Oyamada, Keisuke Ariyoshi, Kota Kihara, Yohei Yamanaka, Kumi Konishi, Kosuke Doki, Yasuyuki Takashima, Manabu Horiuchi, Masato Homma, Takeshi Yamada, Yoshiyuki Yamamoto, Toshikazu Moriwaki, Tatsuya Morita, Atsushi Nakajima & Hiroka Nagaoka. (2022) Rationale and design of a multicenter, double-blinded, randomized, placebo-controlled trial to investigate the effects of naldemedine on opioid-induced constipation for patients with cancer pain: A study protocol. Contemporary Clinical Trials Communications 29, pages 100967.
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Atefeh Noori, Behnam Sadeghirad, Li Wang, Reed A.C. Siemieniuk, Mostafa Shokoohi, Elena Kum, Mark Jeddi, Luis Montoya, Patrick J. Hong, Edward Zhou, Rachel J. Couban, David N. Juurlink, Lehana Thabane, Mohit Bhandari, Gordon H. Guyatt & Jason W. Busse. (2022) Comparative benefits and harms of individual opioids for chronic non-cancer pain: a systematic review and network meta-analysis of randomised trials. British Journal of Anaesthesia 129:3, pages 394-406.
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Michael A. Überall, Heinrich Binsfeld, Michael Küster, Silvia Maurer, Norbert Schürmann & Johannes Horlemann. (2022) Medikamenteninduzierte Verstopfung bei Patienten mit nicht tumorbedingten Schmerzen. Schmerzmedizin 38:5, pages 23-41.
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Michael A. Überall & Gerhard H. H. Müller-Schwefe. (2019) Keine Evidenz für die Abschwächung der analgetischen Opioidwirkung durch peripher wirksame µ‑OpioidrezeptorantagonistenLack of evidence for the inhibition of opioid-related analgesia through peripherally acting μ‑opioid-receptor antagonists. Der Schmerz 34:1, pages 84-85.
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Amer Sebaaly, Marie-José Lahoud, Maroun Rizkallah, Gaby Kreichati & Khalil Kharrat. (2018) Etiology, Evaluation, and Treatment of Failed Back Surgery Syndrome. Asian Spine Journal 12:3, pages 574-585.
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Bart J. Morlion, Stefan A. Mueller‐Lissner, Renato Vellucci, Wojciech Leppert, Benoît C. Coffin, Sara L. Dickerson & Tony O'Brien. (2017) Oral Prolonged‐Release Oxycodone/Naloxone for Managing Pain and Opioid‐Induced Constipation: A Review of the Evidence. Pain Practice 18:5, pages 647-665.
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Alexander M. Ponizovsky, Eli Marom, Abraham Weizman & Eyal Schwartzberg. (2018) Changes in consumption of opioid analgesics in Israel 2009 to 2016: An update focusing on oxycodone and fentanyl formulations. Pharmacoepidemiology and Drug Safety 27:5, pages 535-540.
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Esther S. Kim. (2017) Oxycodone/Naloxone Prolonged Release: A Review in Severe Chronic Pain. Clinical Drug Investigation 37:12, pages 1191-1201.
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Lang Huang, Jian-Guo Zhou, Yu Zhang, Fei Wang, Yi Wang, Da-Hai Liu, Xin-Juan Li, Shui-Ping Lv, Su-Han Jin, Yu-Ju Bai & Hu Ma. (2017) Opioid-Induced Constipation Relief From Fixed-Ratio Combination Prolonged-Release Oxycodone/Naloxone Compared With Oxycodone and Morphine for Chronic Nonmalignant Pain: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Journal of Pain and Symptom Management 54:5, pages 737-748.e3.
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Francesco Amato, Silvia Ceniti, Sergio Mameli, Giovanni M. Pisanu, Renato Vellucci, Vincenzo Palmieri, Leonardo Consoletti, Dorotea Magaldi, Paolo Notaro & Claudio Marcassa. (2017) High dosage of a fixed combination oxycodone/naloxone prolonged release: efficacy and tolerability in patients with chronic cancer pain. Supportive Care in Cancer 25:10, pages 3051-3058.
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Zengdong Meng, Jing Yu, Michael Acuff, Chong Luo, Sanrong Wang, Lehua Yu & Rongzhong Huang. (2017) Tolerability of Opioid Analgesia for Chronic Pain: A Network Meta-Analysis. Scientific Reports 7:1.
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Richard J. Bodnar. (2017) Endogenous Opiates and Behavior: 2015. Peptides 88, pages 126-188.
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Magdalena Kocot-KępskaRenata ZajączkowskaAnna Przeklasa-MuszyńskaJan Dobrogowski. (2017) The role of oxycodone/naloxone in pain management. BÓL 17:4, pages 26-40.
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Zhengqi Pan, Yongjian Qi, Yinxian Wen & Liaobin Chen. (2016) Intravenous morphine titration as a rapid and efficient analgesia for adult patients with femoral shaft fractures after injury. The American Journal of Emergency Medicine 34:11, pages 2107-2111.
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Michael A. Ueberall, Alice Eberhardt & Gerhard H. H. Mueller-Schwefe. (2015) Physicians Experience with and Expectations of the Safety and Tolerability of WHO-Step III Opioids for Chronic (Low) Back Pain: Post Hoc Analysis of Data from a German Cross-Sectional Physician Survey. Pain Research and Treatment 2015, pages 1-8.
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MA Ueberall. (2015) Differential Gastrointestinal Effects of Who-Step III Opioids in Low Back Pain Patients with vs. Without Constipation: Post-Hoc Analysis of Data from a 12-Week Prospective, Open-Label Blinded Endpoint Streamlined Study. Global Journal of Anesthesiology, pages 037-051.
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