Efficacy and Safety Study of Z160 in Subjects With Postherpetic Neuralgia (PHN)

December 11, 2013 updated by: Zalicus

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Z160 in Subjects With Postherpetic Neuralgia

This study will compare Z160 and placebo in patients with Postherpetic Neuralgia for safety and efficacy for a period of 6 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Investigative Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Investigative Site
      • Mesa, Arizona, United States, 85213
        • Investigative Site
      • Peoria, Arizona, United States, 85381
        • Investigative Site
      • Phoenix, Arizona, United States, 85020
        • Investigative Site
      • Scottsdale, Arizona, United States, 85251
        • Investigative Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Investigative Site
    • California
      • Irvine, California, United States, 92618
        • Investigative Site
      • Los Angeles, California, United States, 90033
        • Investigative Site
      • San Francisco, California, United States, 94109
        • Investigative Site
      • Thousand Oaks, California, United States, 91360
        • Investigative Site
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Investigative Site
      • Colorado Springs, Colorado, United States, 80920
        • Investigative Site
      • Denver, Colorado, United States, 80218
        • Investigative Site
    • Florida
      • Brooksville, Florida, United States, 34601
        • Investigative Site
      • Clearwater, Florida, United States, 33756
        • Investigative Site
      • Miami, Florida, United States, 33015
        • Investigative Site
      • Orlando, Florida, United States, 32806
        • Investigative Site
      • Port Orange, Florida, United States, 32127
        • Investigative Site
      • Royal Palm Beach, Florida, United States, 33411
        • Investigative Site
      • Sarasota, Florida, United States, 34243
        • Investigative Site
      • Tampa, Florida, United States, 33606
        • Investigative Site
    • Illinois
      • Chicago, Illinois, United States, 60602
        • Investigative Site
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Investigative Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71105
        • Investigative Site
    • Maryland
      • Columbia, Maryland, United States, 21045
        • Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Investigative Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Investigative Site
      • Bay City, Michigan, United States, 48706
        • Investigative Site
    • Mississippi
      • Ocean Springs, Mississippi, United States, 39564
        • Investigative Site
    • Missouri
      • Hazelwood, Missouri, United States, 63031
        • Investigative Site
      • Kansas City, Missouri, United States, 64114
        • Investigative Site
      • St. Louis, Missouri, United States, 63117
        • Investigative Site
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • Investigative Site
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Investigative Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Investigative Site
    • New York
      • Brooklyn, New York, United States, 11235
        • Investigative Site
      • New York, New York, United States, 10016
        • Investigative Site
    • North Carolina
      • Greensboro, North Carolina, United States, 27410
        • Investigative Site
    • Ohio
      • Beavercreek, Ohio, United States, 45432
        • Investigative Site
      • Columbus, Ohio, United States, 43214
        • Investigative Site
      • Kettering, Ohio, United States, 45429
        • Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Investigative Site
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Investigative Site
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Investigative Site
      • Tullahoma, Tennessee, United States, 37388
        • Investigative Site
    • Texas
      • Austin, Texas, United States, 78731
        • Investigative Site
      • Richardson, Texas, United States, 75080
        • Investigative Site
    • Utah
      • Murray, Utah, United States, 84123
        • Investigative Site
      • Salt Lake City, Utah, United States, 84106
        • Investigative Site
    • Virginia
      • Herndon, Virginia, United States, 20171
        • Investigative Site
    • Washington
      • Bellevue, Washington, United States, 98007
        • Investigative Site
      • Tacoma, Washington, United States, 98405
        • Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provide written informed consent.
  • 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:

  • Severe pain caused by diseases other than PHN.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Z160
375 mg BID
Drug: Z160
PLACEBO_COMPARATOR: Placebo
matching placebo control
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Baseline to Week 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in weekly average pain score
Time Frame: Baseline to Weeks 1, 2, 3, 4, 5, 6
Baseline to Weeks 1, 2, 3, 4, 5, 6
Neuropathic Pain Scale (NPS)
Time Frame: Baseline to Weeks 1, 2, 4, 6
Baseline to Weeks 1, 2, 4, 6
Patient Global Impression of Change (PGIC)
Time Frame: Baseline to Week 6
Baseline to Week 6
Profile of Mood States (POMS)
Time Frame: Baseline to Weeks 1, 2, 4, 6
Baseline to Weeks 1, 2, 4, 6
Daily Sleep Interference Scale (DSIS)
Time Frame: Baseline to Weeks 1, 2, 3, 4, 5, 6
Baseline to Weeks 1, 2, 3, 4, 5, 6
Short Form 36 (SF-36)
Time Frame: Baseline to Week 6
Baseline to Week 6
Z160 plasma concentrations
Time Frame: Baseline to Weeks 1, 2, 4, 6
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
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
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
Baseline to Week 6
Subjects who have >= 50% reduction in average daily pain score
Time Frame: Baseline to Week 6
Baseline to Week 6
Safety and tolerability
Time Frame: Baseline to Weeks 1- 12
As measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events
Baseline to Weeks 1- 12
Amount of rescue medication used
Time Frame: Baseline to Weeks 1, 2, 4 and 6
Baseline to Weeks 1, 2, 4 and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zalicus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 31, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Z160-PHN-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings