An open-label, multicenter study of the safety and efficacy of intrathecal ziconotide for severe chronic pain when delivered via an external pump

Neuromodulation

Volumn 11, Issue 2, 2008, Pages 103-111

  Ver Donck, Ann ^a   Collins, Ronald ^b   Rauck, Richard L ^c   Nitescu, Petre ^d  

^a Multidisciplinary Pain Unit   (Belgium)

^b Center for Pain Management   (United States)

^c Center for Dermatology Research   (United States)

^d SAHLGRENSKA UNIVERSITY HOSPITAL   (Sweden)

Author keywords

External infusion system; Intrathecal; Meningitis; Trialing; Ziconotide

Indexed keywords

MORPHINE; OMEGA CONOTOXIN MVIIA;

ADULT; AGED; ANALGESIA; APPLICATION SITE REACTION; ARTICLE; ASTHENIA; ATAXIA; BLURRED VISION; CEREBROSPINAL FLUID FISTULA; CHRONIC PAIN; CLINICAL GLOBAL IMPRESSION SCALE; CLINICAL TRIAL; CONFUSION; CONSTIPATION; DIZZINESS; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG HALF LIFE; DRUG MECHANISM; DRUG SAFETY; DYSURIA; FEMALE; HEADACHE; HUMAN; INFUSION PUMP; MAJOR CLINICAL STUDY; MALE; MENINGITIS; MULTICENTER STUDY; MUSCLE STIFFNESS; NAUSEA; POSTDURAL PUNCTURE HEADACHE; SOMNOLENCE; TINNITUS; VERTIGO; VISUAL ANALOG SCALE; VOMITING;

EID: 41749093396     PISSN: 10947159     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1525-1403.2008.00150.x     Document Type: Article

References (23)

1. Prialt®. Package insert. San Diego, CA:Elan Pharmaceuticals Inc., 2005.
2. Prialt®. Summary of product characteristics. Shannon, County Clare, Ireland:Elan Pharma International Ltd., 2005.
3. Pirec V, Laurito CE, Lu Y, Yeomans DC. The combined effects of N-type calcium channel blockers and morphine on A delta versus C fiber mediated nociception. Anesth Analg 2001 92:239 243.
4. Miljanich GP. Ziconotide: neuronal calcium channel blocker for treating severe chronic pain. Curr Med Chem 2004 11:3029 3040.
5. Miljanich GP, Ramachandran J. Antagonists of neuronal calcium channels: structure, function, and therapeutic implications. Annu Rev Pharmacol Toxicol 1995 35:707 734.
6. Bohn LM, Gainetdinov RR, Lin FT, Lefkowitz RJ, Caron MG. Mu-opioid receptor desensitization by beta-arrestin-2 determines morphine tolerance but not dependence. Nature 2000 408:720 723.
7. Wang YX, Gao D, Pettus M, Phillips C, Bowersox SS. Interactions of intrathecally administered ziconotide, a selective blocker of neuronal N-type voltage-sensitive calcium channels, with morphine on nociception in rats. Pain 2000 84:271 281.
8. Dissanayake S, Ver Donck A, Vercruysse P, Royal M, Ellis D. No pharmacological tolerance to intrathecal ziconotide observed in chronic pain patients receiving long-term (12 months) treatment. Poster presented at: 4th Congress of the European Federation of the International Association for the Study of Pain Chapters, September 2-6, 2003 Prague, Czech Republic.
9. Staats PS, Yearwood T, Charapata SG et al. Intrathecal ziconotide in the treatment of refractory pain in patients with cancer or AIDS: a randomized controlled trial. JAMA 2004 291:63 70.
10. Rauck RL, Wallace MS, Leong MS et al. A randomized, double-blind, placebo-controlled study of intrathecal ziconotide in adults with severe chronic pain. J Pain Symptom Manage 2006 31:393 406.
11. Wallace MS, Charapata SG, Fisher R et al. Intrathecal ziconotide in the treatment of chronic nonmalignant pain: a randomized, double-blind, placebo-controlled clinical trial. Neuromodulation 2006 9:75 86.
12. Krames ES, Olson K. Clinical realities and economic considerations: patient selection in intrathecal therapy. J Pain Symptom Manage 1997 14:S3 S13.
13. Deer T, Winkelmuller W, Erdine S, Bedder M, Burchiel K. Intrathecal therapy for cancer and nonmalignant pain: patient selection and patient management. Neuromodulation 1999 2:55 66.
14. Follett KA, Boortz-Marx RL, Drake JM et al. Prevention and management of intrathecal drug delivery and spinal cord stimulation system infections. Anesthesiology 2004 100:1582 1594.
15. Panchal SJ, Gonzalez JA. Intrathecal pumps. Tech Reg Anesth Pain Manage 2000 4:137 142.
16. Hassenbusch SJ, Portenoy RK. Current practices in intraspinal therapy - a survey of clinical trends and decision making. J Pain Symptom Manage 2000 20:S4 S11.
17. Nitescu P, Sjoberg M, Appelgren L, Curelaru I. Complications of intrathecal opioids and bupivacaine in the treatment of 'refractory' cancer pain. Clin J Pain 1995 11:45 62.
18. Devulder J, Ghys L, Dhondt W, Rolly G. Spinal analgesia in terminal care: risk versus benefit. J Pain Symptom Manage 1994 9:75 81.
19. Dahm P, Nitescu P, Appelgren L, Curelaru I. Efficacy and technical complications of long-term continuous intraspinal infusions of opioid and/or bupivacaine in refractory nonmalignant pain: a comparison between the epidural and the intrathecal approach with externalized or implanted catheters and infusion pumps. Clin J Pain 1998 14:4 16.
20. Nitescu P, Dahm P, Appelgren L, Curelaru I. Continuous infusion of opioid and bupivacaine by externalized intrathecal catheters in long-term treatment of 'refractory' nonmalignant pain. Clin J Pain 1998 14:17 28.
21. Van Dongen RT, Crul BJ, De Bock M. Long-term intrathecal infusion of morphine and morphine/bupivacaine mixtures in the treatment of cancer pain: a retrospective analysis of 51 cases. Pain 1993 55:119 123.
22. Durand ML, Calderwood SB, Weber DJ et al. Acute bacterial meningitis in adults. A review of 493 episodes. N Engl J Med 1993 328:21 28.
23. Naumann C, Erdine S, Koulousakis A, Van Buyten JP, Schuchard M. Drug adverse events and system complications of intrathecal opioid delivery for pain: origins, detection, manifestations, and management. Neuromodulation 1999 2:92 107.