Analgesic Efficacy and Safety of Oxycodone in Combination With Naloxone as Prolonged Release Tablets in Patients With Moderate to Severe Chronic Pain

Journal of Pain

Volumn 9, Issue 12, 2008, Pages 1144-1154

  Vondrackova, Dana ^a   Leyendecker, Petra ^b   Meissner, Winfried ^c   Hopp, Michael ^b   Szombati, Istvan ^d   Hermanns, Kai ^e   Ruckes, Christian ^b   Weber, Susanne ^b   Grothe, Birgit ^b   Fleischer, Wolfgang ^b   Reimer, Karen ^b,f  

^a UNIVERSITY HOSPITAL BULOVKA   (Czech Republic)

^b Mundipharma Research GmbH Co KG   (Germany)

^c JENA UNIVERSITY HOSPITAL   (Germany)

^d Diagnostics Unit Hungary   (Hungary)

^e Praxis für Suchtakupunktur und Schmerztherapie   (Germany)

^f UNIVERSITY OF WITTEN HERDECKE   (Germany)

Author keywords

bowel function; chronic pain; naloxone; Oxycodone; prolonged release

Indexed keywords

NALOXONE; NALOXONE PLUS OXYCODONE; OXYCODONE; PLACEBO; UNCLASSIFIED DRUG;

ADULT; ANALGESIC ACTIVITY; ARTICLE; CHRONIC PAIN; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE SEVERITY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FATIGUE; FEMALE; GASTROINTESTINAL DISEASE; HEADACHE; HUMAN; LOW BACK PAIN; MAJOR CLINICAL STUDY; MALE; NAUSEA; NEUROLOGIC DISEASE; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SUSTAINED RELEASE FORMULATION; TABLET; VOMITING;

ANALGESICS, OPIOID; CHRONIC DISEASE; CONSTIPATION; DELAYED-ACTION PREPARATIONS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; LOW BACK PAIN; MALE; NALOXONE; NARCOTIC ANTAGONISTS; OXYCODONE; PAIN MEASUREMENT; SEVERITY OF ILLNESS INDEX; TIME FACTORS; TREATMENT OUTCOME;

EID: 56349136276     PISSN: 15265900     EISSN: 15288447     Source Type: Journal    
DOI: 10.1016/j.jpain.2008.06.014     Document Type: Article

References (29)

1. Annunziata K., and Bell T. Impact of opioid-induced constipation on healthcare resource utilisation and patient functioning. Eur J Pain 10 Suppl S1 (2006) S172 (abstract 659)
2. Ballantyne J.C. Opioid analgesia: Perspectives on right use and utility. Pain Physician 10 (2007) 479-491
3. Bell T., Milanova T., Grove G., Williamson R., and Bolge S. OBD symptoms impair quality of life and daily activities, regardless of frequency and duration of opioid treatment: Results of a US patient survey (PROBE survey). J Pain 8 4 Suppl 1 (2007) S71 (abstract 882)
4. Cherny N., Ripamonti C., Pereira J., Davis C., Fallon M., McQuay H., Mercadante S., Pasternak G., Ventafridda V., and Expert Working Group of the European Association of Palliative Care Network. Strategies to manage the adverse effects of oral morphine: An evidence-based report. J Clin Oncol 19 (2001) 2542-2554
5. Choi Y.S., and Billings J.A. Opioid antagonists: A review of their role in palliative care, focusing on use in opioid-related constipation. J Pain Symptom Manage 24 (2002) 71-90
6. Cleeland C.S., and Ryan K.M. Pain assessment: Global use of the Brief Pain Inventory. Ann Acad Med 23 (1994) 129
7. Coluzzi F., and Mattia C. Oxycodone: Pharmacological profile and clinical data in chronic pain management. Minerva Anestesiol 71 (2005) 451-460
8. Coluzzi F., and Pappagallo M. National Initiative on Pain Control: Opioid therapy for chronic noncancer pain: Practice guidelines for initiation and maintenance of therapy. Minerva Anestesiol 71 (2005) 425-433
9. Cook S., Bell T., Sweeney C., Fehnel S., and Hollis K. Impact on quality of life of constipation-associated GI symptoms related to opioid treatment in chronic pain patients: PAC-QOL results from the opioid survey. J Pain 8 4 Suppl 1 (2007) S71 (abstract 883)
10. De Schepper H.U., Cremonini F., Park M.I., and Camilleri M. Opioids and the gut: pharmacology and current clinical experience. Neurogastroenterol Motil 16 (2004) 383-394
11. Gimbel J.S., Richards P., and Portenoy R.K. Controlled-release oxycodone for pain in diabetic neuropathy: A randomized controlled trial. Neurology 60 (2003) 927-934
12. Handelsman L., Cochrane K.J., Aronson M.J., Ness R., Rubinstein K.J., and Kanof P.D. Two new rating scales for opiate withdrawal. Am J Drug Alcohol Abuse 13 (1987) 293-308
13. Holzer P. Opioids and opioid receptors in the enteric nervous system: From a problem in opioid analgesia to a possible new prokinetic therapy in humans. Neurosci Lett 361 (2004) 192-195
14. Hussain A.A., Kimura R., and Huang C.H. Nasal absorption of naloxone and buprenorphine in rats. Int J Pharm 21 (1984) 233-237
15. Kalso E. Oxycodone. J Pain Symptom Manage 29 5 Suppl (2005) S47-S56
16. Kurz A., and Sessler D.I. Opioid-induced bowel dysfunction: Pathophysiology and potential new therapies. Drugs 63 (2003) 649-671
17. Liu M., and Wittbrodt E. Low-dose oral naloxone reverses opioid-induced constipation and analgesia. J Pain Symptom Manage 23 (2002) 48-53
18. Loimer N., Hofmann P., and Chaudhry H.R. Nasal administration of naloxone is as effective as the intravenous route in opiate addicts. Int J Addict 29 (1994) 819-827
19. McMillan S.C. Assessing and managing opiate-induced constipation in adults with cancer. Cancer Control 11 3 Suppl (2004) 3-9
20. Meissner W., Schmidt U., Hartmann M., Kath R., and Reinhart K. Oral naloxone reverses opioid-associated constipation. Pain 84 (2000) 105-109
21. Müller-Lissner S., Leyendecker P., Hopp M., Ruckes C., Fleischer W., and Reimer K. Oral prolonged release (PR) oxycodone/naloxone combination reduces opioid-induced bowel dysfunction (OIBD) in patients with severe chronic pain. Eur J Pain 11 Suppl 1 (2008) S82 (abstract 189)
22. Mucci-LoRusso P., Berman B.S., Silberstein P.T., Citron M.L., Bressler L., Weinstein S.M., Kaiko R.F., Buckley B.J., and Reder R.F. Controlled-release oxycodone compared with controlled-release morphine in the treatment of cancer pain: A randomized, double-blind, parallel-group study. Eur J Pain 2 (1998) 239-249
23. Pappagallo M. Incidence, prevalence, and management of opioid bowel dysfunction. Am J Surg 182 5A Suppl (2001) 11S-18S
24. Sykes N.P. An investigation of the ability of oral naloxone to correct opioid-related constipation in patients with advanced cancer. Palliat Med 10 (1996) 135-144
25. Turk D.C., Dworkin R.H., Allen R.R., Bellamy N., Brandenburg N., Carr D.B., Cleeland C., Dionne R., Farrar J.T., Galer B.S., Hewitt D.J., Jadad A.R., Katz N.P., Kramer L.D., Manning D.C., McCormick C.G., McDermott M.P., McGrath P., Quessy S., Rappaport B.A., Robinson J.P., Royal M.A., Simon L., Stauffer J.W., Stein W., Tollett J., and Witter J. Core outcome domains for chronic pain clinical trials: IMMPACT recommendations. Pain 106 (2003) 337-345
26. Watson C.P., and Babul N. Efficacy of oxycodone in neuropathic pain: A randomized trial in postherpetic neuralgia. Neurology 50 (1998) 1837-1841
27. Watson C.P.N., Moulin D., Watt-Watson J., Gordon A., and Eisenhoffer J. Controlled-release oxycodone relieves neuropathic pain: A randomized controlled trial in painful diabetic neuropathy. Pain 105 (2003) 71-78
28. Wei L.J., Lin D.Y., and Weissfeld L. Regression analysis of multivariate incomplete failure time data by modeling marginal distributions. J Am Stat Assoc 84 (1989) 1065-1073
29. Zeng D., and Lin D.Y. Maximum likelihood estimation in semiparametric regression models with censored data. J R Statist Soc B 69 Part 4 (2007) 1-30