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Phase II, open-label, multicenter study of combined intrathecal morphine and ziconotide: addition of ziconotide in patients receiving intrathecal morphine for severe chronic pain.
Pain Med. 2008 Apr; 9(3):271-81.PM

Abstract

OBJECTIVE

To assess the safety and efficacy of adding intrathecal ziconotide to intrathecal morphine in patients being treated with a stable intrathecal morphine dose.

DESIGN

Phase II, multicenter, open-label study with a 5-week titration phase and an extension phase.

SETTING

Outpatient clinics.

PATIENTS

Patients with suboptimal pain relief receiving stable intrathecal morphine doses (2-20 mg/day).

INTERVENTIONS

Intrathecal morphine dosing remained constant during the titration phase. Ziconotide therapy began at 0.60 microg/day and was titrated to a maximum of 7.2 microg/day. During the extension phase, ziconotide and intrathecal morphine dosing were adjusted at the investigator's discretion.

OUTCOME MEASURES

Safety was assessed primarily via adverse event reports. Efficacy was analyzed via percentage change on the visual analog scale of pain intensity and in weekly systemic opioid consumption.

RESULTS

Twenty-six patients were enrolled. Treatment-emergent adverse events were generally mild or moderate; the most common (> or = 15% of patients in either study phase) study drug-related (i.e., ziconotide/morphine combination [or ziconotide monotherapy in the extension phase only]) events were confusion, dizziness, abnormal gait, hallucinations, and anxiety. The mean percentage improvement in visual analog scale of pain intensity scores was 14.5% (95% confidence interval: -9.4% to 38.5%) from baseline to week 5 and varied during the extension phase (range: -0.4% to 42.8%). Mean percentage change from baseline in systemic opioid consumption was -14.3% at week 5 and varied considerably during the extension phase.

CONCLUSIONS

Ziconotide, combined with stable intrathecal morphine, may reduce pain and decrease systemic opioid use in patients with pain inadequately controlled by intrathecal morphine alone.

Authors+Show Affiliations

University of California, San Diego School of Medicine, La Jolla, California, USA. mswallace@ucsd.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18366507

Citation

Wallace, Mark S., et al. "Phase II, Open-label, Multicenter Study of Combined Intrathecal Morphine and Ziconotide: Addition of Ziconotide in Patients Receiving Intrathecal Morphine for Severe Chronic Pain." Pain Medicine (Malden, Mass.), vol. 9, no. 3, 2008, pp. 271-81.
Wallace MS, Kosek PS, Staats P, et al. Phase II, open-label, multicenter study of combined intrathecal morphine and ziconotide: addition of ziconotide in patients receiving intrathecal morphine for severe chronic pain. Pain Med. 2008;9(3):271-81.
Wallace, M. S., Kosek, P. S., Staats, P., Fisher, R., Schultz, D. M., & Leong, M. (2008). Phase II, open-label, multicenter study of combined intrathecal morphine and ziconotide: addition of ziconotide in patients receiving intrathecal morphine for severe chronic pain. Pain Medicine (Malden, Mass.), 9(3), 271-81. https://doi.org/10.1111/j.1526-4637.2007.00355.x
Wallace MS, et al. Phase II, Open-label, Multicenter Study of Combined Intrathecal Morphine and Ziconotide: Addition of Ziconotide in Patients Receiving Intrathecal Morphine for Severe Chronic Pain. Pain Med. 2008;9(3):271-81. PubMed PMID: 18366507.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Phase II, open-label, multicenter study of combined intrathecal morphine and ziconotide: addition of ziconotide in patients receiving intrathecal morphine for severe chronic pain. AU - Wallace,Mark S, AU - Kosek,Peter S, AU - Staats,Peter, AU - Fisher,Robert, AU - Schultz,David M, AU - Leong,Michael, PY - 2008/3/28/pubmed PY - 2008/6/25/medline PY - 2008/3/28/entrez SP - 271 EP - 81 JF - Pain medicine (Malden, Mass.) JO - Pain Med VL - 9 IS - 3 N2 - OBJECTIVE: To assess the safety and efficacy of adding intrathecal ziconotide to intrathecal morphine in patients being treated with a stable intrathecal morphine dose. DESIGN: Phase II, multicenter, open-label study with a 5-week titration phase and an extension phase. SETTING: Outpatient clinics. PATIENTS: Patients with suboptimal pain relief receiving stable intrathecal morphine doses (2-20 mg/day). INTERVENTIONS: Intrathecal morphine dosing remained constant during the titration phase. Ziconotide therapy began at 0.60 microg/day and was titrated to a maximum of 7.2 microg/day. During the extension phase, ziconotide and intrathecal morphine dosing were adjusted at the investigator's discretion. OUTCOME MEASURES: Safety was assessed primarily via adverse event reports. Efficacy was analyzed via percentage change on the visual analog scale of pain intensity and in weekly systemic opioid consumption. RESULTS: Twenty-six patients were enrolled. Treatment-emergent adverse events were generally mild or moderate; the most common (> or = 15% of patients in either study phase) study drug-related (i.e., ziconotide/morphine combination [or ziconotide monotherapy in the extension phase only]) events were confusion, dizziness, abnormal gait, hallucinations, and anxiety. The mean percentage improvement in visual analog scale of pain intensity scores was 14.5% (95% confidence interval: -9.4% to 38.5%) from baseline to week 5 and varied during the extension phase (range: -0.4% to 42.8%). Mean percentage change from baseline in systemic opioid consumption was -14.3% at week 5 and varied considerably during the extension phase. CONCLUSIONS: Ziconotide, combined with stable intrathecal morphine, may reduce pain and decrease systemic opioid use in patients with pain inadequately controlled by intrathecal morphine alone. SN - 1526-4637 UR - https://www.unboundmedicine.com/medline/citation/18366507/Phase_II_open_label_multicenter_study_of_combined_intrathecal_morphine_and_ziconotide:_addition_of_ziconotide_in_patients_receiving_intrathecal_morphine_for_severe_chronic_pain_ DB - PRIME DP - Unbound Medicine ER -