Clinical Trial: Phase 2 Efficacy Trial of Z160 in Lumbosacral Radiculopathy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate The Efficacy and Safety of Z160 in Subjects With Neuropathic Pain From Lumbosacral

  • Change in weekly average of daily pain scores (PI-NRS) [ Time Frame: Baseline to weeks 1,2,3,4,5, 6 ]
  • Galer Neuropathic Pain Scale (NPS) [ Time Frame: Baseline to weeks 1,2,4,6 ]
  • Patient Global Impression of Change (PGIC) [ Time Frame: Baseline to week 6 ]
  • Modified Roland-Morris Disability Scale (RMDQ) [ Time Frame: Baseline to weeks 1,2,4,6 ]
  • Rescue medication use [ Time Frame: Weeks 1,2,3,4,5,6 ]
  • Profile of Mood States (POMS) [ Time Frame: Baseline to weeks 1,2,4,6 ]
  • Daily Sleep Interference Scale [ Time Frame: Baseline to weeks 1,2,3,4,5,6 ]
  • Short Form 36 (SF-36) [ Time Frame: Baseline to week 6 ]
  • Safety and tolerability [ Time Frame: Baseline, weeks 1,2,3,4,5,6,7,12 ]
    Adverse events, ECG, labs
  • Relationship of plasma concentrations [ Time Frame: Baseline to weeks 1,2,3,4,5,6 ]
  • Time to a 30% reduction in average daily pain score [ Time Frame: Baseline to weeks 1,2,3,4,5,6 ]
  • Time to a 50% reduction in average daily pain score [ Time Frame: Baseline to weeks 1,2,3,4,5,6 ]
  • Subjects who have greater than or equal to a 30% reduction in average daily pain score [ Time Frame: Baseline to weeks 1,2,3,4,5,6 ]
  • Subjects who have greater than or equal to a 50% reduction in average daily pain score [ Time Frame: Baseline to weeks 1,2,3,4,5,6 ]


    • Original Secondary Outcome:

    • Change in average daily pain score (PI-NRS) [ Time Frame: Baseline to weeks 1,2,3,4,5 ]
    • Galer Neuropathic Pain Scale (NPS) [ Time Frame: Baseline to weeks 1,2,4,6 ]
    • Patient Global Impression of Change (PGIC) [ Time Frame: Baseline to week 6 ]
    • Modified Roland-Morris Disability Scale (RMDQ) [ Time Frame: Baseline to weeks 1,2,4,6 ]
    • Rescue medication use [ Time Frame: Weeks 1,2,3,4,5,6 ]
    • Profile of Mood States (POMS) [ Time Frame: Baseline to weeks 1,2,4,6 ]
    • Daily Sleep Interference Scale [ Time Frame: Baseline to weeks 1,2,3,4,5,6 ]
    • Short Form 36 (SF-36) [ Time Frame: Baseline to week 6 ]
    • Safety and tolerability [ Time Frame: Baseline, weeks 1,2,3,4,5,6,7,12 ]
      Adverse events, ECG, labs
    • Relationship of plasma concentrations [ Time Frame: Baseline to weeks 1,2,3,4,5,6 ]
    • Time to a 30% reduction in average daily pain score [ Time Frame: Baseline to weeks 1,2,3,4,5,6 ]
    • Time to a 50% reduction in average daily pain score [ Time Frame: Baseline to weeks 1,2,3,4,5,6 ]
    • Subjects who have greater than or equal to a 30% reduction in average daily pain score [ Time Frame: Baseline to weeks 1,2,3,4,5,6 ]
    • Subjects who have greater than or equal to a 50% reduction in average daily pain score [ Time Frame: Baseline to weeks 1,2,3,4,5,6 ]


    Information By: Zalicus

    Dates:
    Date Received: July 26, 2012
    Date Started: August 2012
    Date Completion:
    Last Updated: December 11, 2013
    Last Verified: December 2013