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A randomized, double-blind, placebo-controlled study of intrathecal ziconotide in adults with severe chronic pain.
J Pain Symptom Manage. 2006 May; 31(5):393-406.JP

Abstract

Safety and efficacy data from a study of slow intrathecal (IT) ziconotide titration for the management of severe chronic pain are presented. Patients randomized to ziconotide (n = 112) or placebo (n = 108) started IT infusion at 0.1 microg/hour (2.4 microg/day), increasing gradually (0.05-0.1 microg/hour increments) over 3 weeks. The ziconotide mean dose at termination was 0.29 microg/hour (6.96 microg/day). Patients' baseline Visual Analogue Scale of Pain Intensity (VASPI) score was 80.7 (SD 15). Statistical significance was noted for VASPI mean percentage improvement, baseline to Week 3 (ziconotide [14.7%] vs. placebo [7.2%; P = 0.036]) and many of the secondary efficacy outcomes measures. Significant adverse events (AEs) reported in the ziconotide group were dizziness, confusion, ataxia, abnormal gait, and memory impairment. Discontinuation rates for AEs and serious AEs were comparable for both groups. Slow titration of ziconotide, a nonopioid analgesic, to a low maximum dose resulted in significant improvement in pain and was better tolerated than in two previous controlled trials that used a faster titration to a higher mean dose.

Authors+Show Affiliations

Rauck RL
Wake Forest University School of Medicine, The Center for Clinical Research, Carolinas Pain Institute, Winston-Salem, North Carolina 27103, USA. RRauck@ccrpain.com
Wallace MS
No affiliation info available
Leong MS
No affiliation info available
Minehart M
No affiliation info available
Webster LR
No affiliation info available
Charapata SG
No affiliation info available
Abraham JE
No affiliation info available
Buffington DE
No affiliation info available
Ellis D
No affiliation info available
Kartzinel R
No affiliation info available
Ziconotide 301 Study Group
No affiliation info available

MeSH

AdultAgedAnalgesics, Non-NarcoticChronic DiseaseDouble-Blind MethodFemaleHumansInjections, SpinalMaleMiddle AgedPainPlacebosomega-Conotoxins

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16716870

Citation

Rauck, Richard L., et al. "A Randomized, Double-blind, Placebo-controlled Study of Intrathecal Ziconotide in Adults With Severe Chronic Pain." Journal of Pain and Symptom Management, vol. 31, no. 5, 2006, pp. 393-406.
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(5):393-406.
Rauck, R. L., Wallace, M. S., Leong, M. S., Minehart, M., Webster, L. R., Charapata, S. G., Abraham, J. E., Buffington, D. E., Ellis, D., & Kartzinel, R. (2006). A randomized, double-blind, placebo-controlled study of intrathecal ziconotide in adults with severe chronic pain. Journal of Pain and Symptom Management, 31(5), 393-406.
Rauck RL, et al. A Randomized, Double-blind, Placebo-controlled Study of Intrathecal Ziconotide in Adults With Severe Chronic Pain. J Pain Symptom Manage. 2006;31(5):393-406. PubMed PMID: 16716870.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, double-blind, placebo-controlled study of intrathecal ziconotide in adults with severe chronic pain. AU - Rauck,Richard L, AU - Wallace,Mark S, AU - Leong,Michael S, AU - Minehart,Michael, AU - Webster,Lynn R, AU - Charapata,Steven G, AU - Abraham,Jacob E, AU - Buffington,Daniel E, AU - Ellis,David, AU - Kartzinel,Ronald, AU - ,, PY - 2005/10/24/accepted PY - 2006/5/24/pubmed PY - 2006/8/1/medline PY - 2006/5/24/entrez SP - 393 EP - 406 JF - Journal of pain and symptom management JO - J Pain Symptom Manage VL - 31 IS - 5 N2 - Safety and efficacy data from a study of slow intrathecal (IT) ziconotide titration for the management of severe chronic pain are presented. Patients randomized to ziconotide (n = 112) or placebo (n = 108) started IT infusion at 0.1 microg/hour (2.4 microg/day), increasing gradually (0.05-0.1 microg/hour increments) over 3 weeks. The ziconotide mean dose at termination was 0.29 microg/hour (6.96 microg/day). Patients' baseline Visual Analogue Scale of Pain Intensity (VASPI) score was 80.7 (SD 15). Statistical significance was noted for VASPI mean percentage improvement, baseline to Week 3 (ziconotide [14.7%] vs. placebo [7.2%; P = 0.036]) and many of the secondary efficacy outcomes measures. Significant adverse events (AEs) reported in the ziconotide group were dizziness, confusion, ataxia, abnormal gait, and memory impairment. Discontinuation rates for AEs and serious AEs were comparable for both groups. Slow titration of ziconotide, a nonopioid analgesic, to a low maximum dose resulted in significant improvement in pain and was better tolerated than in two previous controlled trials that used a faster titration to a higher mean dose. SN - 0885-3924 UR - https://www.unboundmedicine.com/medline/citation/16716870/A_randomized_double_blind_placebo_controlled_study_of_intrathecal_ziconotide_in_adults_with_severe_chronic_pain_ DB - PRIME DP - Unbound Medicine ER -