Efficacy and Safety Study of Z160 in Subjects With Postherpetic Neuralgia
NCT ID: NCT01757873
Last Updated: 2013-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
144 participants
INTERVENTIONAL
2012-12-31
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Z160
375 mg BID
Z160
Placebo
matching placebo control
Placebo
Interventions
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Z160
Placebo
Eligibility Criteria
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Inclusion Criteria
* Either sex but must be aged \>=18 years.
* Diagnosis of PHN as defined by the presence of pain in the area affected by herpes zoster \>=6 months after the herpes zoster skin rash has healed.
* Pain score over the last week of \>=3 and \<=8 on the PI-NRS
* If female, the subject must be postmenopausal , surgically sterilized for \>=3 months before the screening visit, or agree to use 2 reliable methods of contraception if of childbearing potential. If male, the subject must agree to use condoms.
* Willing and able to comply with all study procedures.
Exclusion Criteria
* Neurolytic or neurosurgical therapy for PHN within 6 months of screening (subjects who received a spinal cord stimulator implant at least 6 months before screening are eligible, but the settings need to remain stable during the double blind study period without use of a magnet).
* History of seizure, excluding pediatric febrile seizures, or currently has seizures.
* Stroke or transient ischemic attack (TIA) \<=6 months before the screening visit.
* History of or a current diagnosis of schizophrenia or bipolar disorder.
* Major depressive disorder or generalized anxiety disorder \<=6 months before the screening visit. Subjects who are on stable doses of selective serotonin uptake inhibitors (SSRIs) for depression (other than major depressive disorder) are eligible for the study.
* Clinically significant alcohol or substance dependency \<=1 year before the screening visit
* Imminent risk of suicide (positive response to question 4 or 5 on the C-SSRS) or had a suicide attempt within 6 months before the screening visit.
* Clinically significant conditions that, in the investigator's opinion, may interfere with the study procedures or compromise the subject's safety.
* Malignancy (other than nonmetastatic basal or squamous cell carcinoma of the skin or carcinoma in situ of other organs that was surgically removed \>1 year before screening and has not recurred).
* Condition that is known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
* Illness within 30 days before screening.
* History of hypersensitivity to calcium channel blockers.
* Multiple drug allergies
* Opioids (at doses exceeding the equivalent of 15 mg of oral morphine) or a high-dose capsaicin patch (Qutenza) \<=30 days before the screening visit.
* Moderate or strong cytochrome P450 inducer within 30 days before the screening visit.
* Digoxin or prohibited medications that cannot be discontinued before randomization.
* Other exclusions apply.
18 Years
ALL
No
Sponsors
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Zalicus
INDUSTRY
Responsible Party
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Locations
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Investigative Site
Birmingham, Alabama, United States
Investigative Site
Chandler, Arizona, United States
Investigative Site
Mesa, Arizona, United States
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Peoria, Arizona, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Little Rock, Arkansas, United States
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Irvine, California, United States
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Los Angeles, California, United States
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San Francisco, California, United States
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Thousand Oaks, California, United States
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Boulder, Colorado, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Brooksville, Florida, United States
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Clearwater, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Port Orange, Florida, United States
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Royal Palm Beach, Florida, United States
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Sarasota, Florida, United States
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Tampa, Florida, United States
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Chicago, Illinois, United States
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Evansville, Indiana, United States
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Shreveport, Louisiana, United States
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Columbia, Maryland, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Bay City, Michigan, United States
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Ocean Springs, Mississippi, United States
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Hazelwood, Missouri, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Toms River, New Jersey, United States
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Albuquerque, New Mexico, United States
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Brooklyn, New York, United States
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New York, New York, United States
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Greensboro, North Carolina, United States
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Beavercreek, Ohio, United States
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Columbus, Ohio, United States
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Kettering, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Charleston, South Carolina, United States
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Nashville, Tennessee, United States
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Tullahoma, Tennessee, United States
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Austin, Texas, United States
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Richardson, Texas, United States
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Murray, Utah, United States
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Salt Lake City, Utah, United States
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Herndon, Virginia, United States
Investigative Site
Bellevue, Washington, United States
Investigative Site
Tacoma, Washington, United States
Countries
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Other Identifiers
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Z160-PHN-202
Identifier Type: -
Identifier Source: org_study_id