PMID- 16716870
OWN - NLM
STAT- MEDLINE
DCOM- 20060731
LR  - 20220408
IS  - 0885-3924 (Print)
IS  - 0885-3924 (Linking)
VI  - 31
IP  - 5
DP  - 2006 May
TI  - A randomized, double-blind, placebo-controlled study of intrathecal ziconotide in 
      adults with severe chronic pain.
PG  - 393-406
AB  - 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.
FAU - Rauck, Richard L
AU  - Rauck RL
AD  - Wake Forest University School of Medicine, The Center for Clinical Research, 
      Carolinas Pain Institute, Winston-Salem, North Carolina 27103, USA. 
      RRauck@ccrpain.com
FAU - Wallace, Mark S
AU  - Wallace MS
FAU - Leong, Michael S
AU  - Leong MS
FAU - Minehart, Michael
AU  - Minehart M
FAU - Webster, Lynn R
AU  - Webster LR
FAU - Charapata, Steven G
AU  - Charapata SG
FAU - Abraham, Jacob E
AU  - Abraham JE
FAU - Buffington, Daniel E
AU  - Buffington DE
FAU - Ellis, David
AU  - Ellis D
FAU - Kartzinel, Ronald
AU  - Kartzinel R
CN  - Ziconotide 301 Study Group
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Pain Symptom Manage
JT  - Journal of pain and symptom management
JID - 8605836
RN  - 0 (Analgesics, Non-Narcotic)
RN  - 0 (Placebos)
RN  - 0 (omega-Conotoxins)
RN  - 7I64C51O16 (ziconotide)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Analgesics, Non-Narcotic/*administration & dosage/adverse effects
MH  - Chronic Disease
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Injections, Spinal
MH  - Male
MH  - Middle Aged
MH  - Pain/*drug therapy
MH  - Placebos
MH  - omega-Conotoxins/*administration & dosage/adverse effects
EDAT- 2006/05/24 09:00
MHDA- 2006/08/01 09:00
CRDT- 2006/05/24 09:00
PHST- 2005/10/24 00:00 [accepted]
PHST- 2006/05/24 09:00 [pubmed]
PHST- 2006/08/01 09:00 [medline]
PHST- 2006/05/24 09:00 [entrez]
AID - S0885-3924(06)00187-4 [pii]
AID - 10.1016/j.jpainsymman.2005.10.003 [doi]
PST - ppublish
SO  - J Pain Symptom Manage. 2006 May;31(5):393-406. doi: 
      10.1016/j.jpainsymman.2005.10.003.