This study will compare Z160 and placebo in patients with Postherpetic Neuralgia for safety and efficacy for a period of 6 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
144
Change from baseline to Week 6 in the weekly average pain score based on Pain Intensity-Numeric Rating Scale (PI-NRS)
Time frame: Baseline to Week 6
Change from baseline in weekly average pain score
Time frame: Baseline to Weeks 1, 2, 3, 4, 5, 6
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
Profile of Mood States (POMS)
Time frame: Baseline to Weeks 1, 2, 4, 6
Daily Sleep Interference Scale (DSIS)
Time frame: Baseline to Weeks 1, 2, 3, 4, 5, 6
Short Form 36 (SF-36)
Time frame: Baseline to Week 6
Z160 plasma concentrations
Time frame: Baseline to Weeks 1, 2, 4, 6
Time to a >= 30% reduction in weekly average pain score
Time frame: Baseline to Weeks 1, 2, 3, 4, 5, 6
Time to a >= 50% reduction in weekly average pain score
Time frame: Baseline to Weeks 1, 2, 3, 4, 5, 6
Subjects who have >= 30% reduction in average daily pain score
Time frame: Baseline to Week 6
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Investigative Site
Birmingham, Alabama, United States
Investigative Site
Chandler, Arizona, United States
Investigative Site
Mesa, Arizona, United States
Investigative Site
Peoria, Arizona, United States
Investigative Site
Phoenix, Arizona, United States
Investigative Site
Scottsdale, Arizona, United States
Investigative Site
Little Rock, Arkansas, United States
Investigative Site
Irvine, California, United States
Investigative Site
Los Angeles, California, United States
Investigative Site
San Francisco, California, United States
...and 43 more locations
Subjects who have >= 50% reduction in average daily pain score
Time frame: Baseline to Week 6
Safety and tolerability
As measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events
Time frame: Baseline to Weeks 1- 12
Amount of rescue medication used
Time frame: Baseline to Weeks 1, 2, 4 and 6