PMID- 22151630
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20121002
LR  - 20220310
IS  - 1094-7159 (Print)
IS  - 1094-7159 (Linking)
VI  - 9
IP  - 2
DP  - 2006 Apr
TI  - Intrathecal ziconotide in the treatment of chronic nonmalignant pain: a 
      randomized, double-blind, placebo-controlled clinical trial.
PG  - 75-86
LID - 10.1111/j.1525-1403.2006.00055.x [doi]
AB  - Objective.  The safety and efficacy of intrathecal (IT) ziconotide was studied in 
      a randomized, double-blind, placebo-controlled trial. Materials and Methods.  
      Patients (169 ziconotide, 86 placebo) with severe chronic nonmalignant pain 
      unresponsive to conventional therapy and a visual analog scale of pain intensity 
      (VASPI score) >/= 50 mm were treated over a 6-day period in an inpatient hospital 
      setting. Initial starting dose was 0.4 microg/hour and was titrated to analgesia or 
      intolerance (maximum dose 7.0 microg/hour). The starting and maximum doses were 
      reduced to 0.1 microg/hour and 2.4 microg/hour, respectively, due to adverse events 
      (AEs). Results.  The mean percent reduction in VASPI score from baseline was 
      31.2% and 6.0% for ziconotide- and placebo-treated patients, respectively 
      (p </= 0.001). During the initial titration phase, a significantly greater 
      percentage of patients in the ziconotide group compared to the placebo group 
      reported AEs, including abnormal gait, amblyopia, dizziness, nausea, nystagmus, 
      pain, urinary retention, and vomiting. Conclusion.  Ziconotide provided 
      significant analgesia in patients for whom conventional therapy failed. However, 
      there was a considerable incidence of ziconotide-associated AEs due to the rapid 
      titration and high doses administered.
FAU - Wallace, Mark S
AU  - Wallace MS
AD  - University of California San Diego Medical Center, La Jolla, Calif; Heartland 
      Spine and Specialty Hospital, Kansas City, Mo; R.C. Goodman Institute for Pain 
      Management, Fort Smith, Ark; Emory University Center for Pain Medicine, Atlanta, 
      Ga; Metzger Pain Management, Shrewsbury, NJ; Genitope, Redwood City, Calif; 
      Avigen Inc., Alameda, Calif; Elan Pharmaceuticals Inc., San Diego, Calif, USA.
FAU - Charapata, Steven G
AU  - Charapata SG
FAU - Fisher, Robert
AU  - Fisher R
FAU - Byas-Smith, Michael
AU  - Byas-Smith M
FAU - Staats, Peter S
AU  - Staats PS
FAU - Mayo, Martha
AU  - Mayo M
FAU - McGuire, Dawn
AU  - McGuire D
FAU - Ellis, David
AU  - Ellis D
CN  - Ziconotide Nonmalignant Pain Study 96-002 Group
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Neuromodulation
JT  - Neuromodulation : journal of the International Neuromodulation Society
JID - 9804159
EDAT- 2006/04/01 00:00
MHDA- 2006/04/01 00:01
CRDT- 2011/12/14 06:00
PHST- 2011/12/14 06:00 [entrez]
PHST- 2006/04/01 00:00 [pubmed]
PHST- 2006/04/01 00:01 [medline]
AID - S1094-7159(11)60255-9 [pii]
AID - 10.1111/j.1525-1403.2006.00055.x [doi]
PST - ppublish
SO  - Neuromodulation. 2006 Apr;9(2):75-86. doi: 10.1111/j.1525-1403.2006.00055.x.