PMID- 17319450
OWN - NLM
STAT- MEDLINE
DCOM- 20070405
LR  - 20191110
IS  - 1551-7489 (Print)
IS  - 1551-7489 (Linking)
VI  - 2
IP  - 3
DP  - 2006 May-Jun
TI  - A Phase II, multicenter, randomized, double-blind, placebo-controlled crossover 
      study of CJC-1008--a long-acting, parenteral opioid analgesic--in the treatment 
      of postherpetic neuralgia.
PG  - 167-73
AB  - INTRODUCTION: CJC-1008 is a chemical modification of the opioid peptide dynorphin 
      A (1-13) (Dyn A) that promotes dynorphin's covalent attachment to human serum 
      albumin in vivo after administration, thus prolonging its duration of action. The 
      primary objective of this study was to evaluate the preliminary efficacy and 
      safety of CJC-1008 as compared with placebo in patients with postherpetic 
      neuralgia (PHN). METHODS: Patients with PHN were assigned 1:1 to receive active 
      study medication or placebo. After dosing, measurements were made every 15 
      minutes for the first hour; at two, three, four, six, and eight hours postdose; 
      and during return visits to the study site after two, seven, and 28 days (as 
      necessary), as well as during precrossover and exit visits. These measurements 
      examined: 1) overall pain intensity, 2) pain intensity for each individual PHN 
      type, 3) categorical overall pain intensity, 4) categorical pain relief and 5) 
      adverse events (AEs). When PHN pain intensity returned to baseline and/or at 
      patients' first request for rescue analgesia other than acetaminophen (typically 
      around 28 days after dosing but sometimes as soon as two days postdose), patients 
      were to cross over to the alternative treatment and be monitored on the same 
      schedule. RESULTS: A substantial placebo response was observed, but the analgesic 
      effect observed in the active group was greater than that in the placebo group 
      for the first eight hours. By 24 hours, the difference was not significant. A 
      total of 29 out of 30 patients (96 percent) experienced at least one 
      treatment-emergent AE during active drug treatment, while 14 of 27 patients (52 
      percent) reported such AEs during placebo treatment. Of the AEs occurring within 
      the first eight hours after dosing, 97 percent were reported during treatment 
      with active drug and 3 percent were reported during treatment with placebo. The 
      majority of these AEs were mild in intensity. DISCUSSION: This study provides 
      evidence of a greater analgesic effect when using CJC-1008 compared to placebo in 
      patients with PHN. However, the effect only lasted through eight hours postdose 
      and diminished by 24 hours. This study provides evidence of a peripheral action 
      of dynorphin, since CJC-1008 does not cross the blood-brain barrier.
FAU - Wallace, Mark S
AU  - Wallace MS
AD  - Department of Anesthesiology, University of California San Diego, USA.
FAU - Moulin, Dwight
AU  - Moulin D
FAU - Clark, A J M
AU  - Clark AJ
FAU - Wasserman, Ronald
AU  - Wasserman R
FAU - Neale, Ann
AU  - Neale A
FAU - Morley-Forster, Patricia
AU  - Morley-Forster P
FAU - Castaigne, Jean-Paul
AU  - Castaigne JP
FAU - Teichman, Sam
AU  - Teichman S
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Opioid Manag
JT  - Journal of opioid management
JID - 101234523
RN  - 0 (Analgesics, Opioid)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Peptide Fragments)
RN  - 72957-38-1 (dynorphin (1-13))
RN  - 74913-18-1 (Dynorphins)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Analgesics, Opioid/*administration & dosage/adverse effects/pharmacokinetics
MH  - Delayed-Action Preparations/administration & dosage/adverse 
      effects/pharmacokinetics
MH  - Double-Blind Method
MH  - Dynorphins/*administration & dosage/adverse effects/pharmacokinetics
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neuralgia, Postherpetic/*drug therapy
MH  - Peptide Fragments/*administration & dosage/adverse effects/pharmacokinetics
MH  - Time Factors
EDAT- 2007/02/27 09:00
MHDA- 2007/04/06 09:00
CRDT- 2007/02/27 09:00
PHST- 2007/02/27 09:00 [pubmed]
PHST- 2007/04/06 09:00 [medline]
PHST- 2007/02/27 09:00 [entrez]
AID - 10.5055/jom.2006.0026 [doi]
PST - ppublish
SO  - J Opioid Manag. 2006 May-Jun;2(3):167-73. doi: 10.5055/jom.2006.0026.