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An Effectiveness and Safety Study With RWJ-333369 (Carisbamate) for the Study of Postherpetic Neuralgia (PHN).

Primary Purpose

Postherpetic Neuralgia, Neuralgia, Herpes Zoster

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
placebo
carisbamate
Sponsored by
SK Life Science, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postherpetic Neuralgia focused on measuring pain following the healing of rashes and blisters, herpes virus, rash, varicella-zoster virus, shingles.

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of postherpetic neuralgia (PHN) with a history of varicella-zoster rash (shingles), persistent pain for at least 6 months after the healing of the rash
  • Experienced postherpetic neuralgia pain on a daily basis for the past 3 months
  • Women must be postmenopausal for at least 2 years, sexually abstinent, or if sexually active, be practicing an effective method of birth control, and have a negative serum pregnancy test at screening.

Exclusion Criteria:

  • History of a poor response to 3 or more medications for postherpetic neuralgia (PHN), with poor response defined as treatment with medications in the following categories of therapy for at least 1 month at therapeutic dosages without at least moderate improvement, as judged by the study doctor: Antiepileptic drugs, antidepressants, serotonin norepinephrine uptake inhibitors (SNRIs), opioid analgesics, or lidocaine patch
  • currently taking tricyclic antidepressants, Coumadin (warfarin), or continued treatment with an antiepileptic drug for any indication, Note: If taking these medications, to be eligible for the study, they must be tapered and discontinued
  • past neurolytic treatment (destruction of nerves by the application of chemicals, heat or cold, neurosurgery, intrathecal pumps, or spinal cord stimulators for PHN pain
  • currently using herbal topical creams or ointments for pain relief within 48 hours, capsaicin within 6 months, or systemic corticosteroids within 3 months of the baseline period
  • Prior exposure to RWJ-333369 (carisbamate).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    002

    001

    Arm Description

    placebo twice daily for 4 weeks

    carisbamate 200 mg tablet twice daily for 4 weeks

    Outcomes

    Primary Outcome Measures

    The mean of the last 7 average daily PHN scores of the first treatment period on days when study drug is taken.

    Secondary Outcome Measures

    The means of the last 7 average daily PHN pain scores with no use of rescue medication, the last 7 current daily PHN pain scores, the last 7 maximum daily PHN pain scores and the last 7 daily sleep interference scores.

    Full Information

    First Posted
    June 25, 2007
    Last Updated
    April 27, 2018
    Sponsor
    SK Life Science, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00492323
    Brief Title
    An Effectiveness and Safety Study With RWJ-333369 (Carisbamate) for the Study of Postherpetic Neuralgia (PHN).
    Official Title
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group With a Crossover Confirmation Period Study of RWJ-333369 for the Treatment of Postherpetic Neuralgia.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2007 (undefined)
    Primary Completion Date
    June 2008 (Actual)
    Study Completion Date
    June 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SK Life Science, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the safety, effectiveness, and tolerability of 200 mg of RWJ-333369 given twice daily compared with placebo in the treatment of postherpetic neuralgia.
    Detailed Description
    Postherpetic neuralgia is a distressing syndrome of neuropathic pain that continues for at least 3 months after the resolution of the varicella-zoster rash (shingles), can last up to years later, and for which therapies are often limited by incomplete pain relief and side effects. This is a randomized (study medication is assigned by chance), double-blind (neither the Investigator or the patient know the name of the assigned study medication), placebo-controlled, crossover, parallel-group, multicenter study to determine the effectiveness and safety of 200 mg of RWJ-333369 given twice daily for 4 weeks compared with placebo in patients with Postherpetic Neuralgia (PHN). The study hypothesis is that 200 mg of RWJ-333369 given twice daily for 4 weeks will be more effective than placebo in reducing pain due to PHN, as measured by average daily PHN pain scores. Patients will receive 200 mg of RWJ-333369 or matching placebo tablets, given in equally divided doses twice daily by mouth, with or without food, for 4 weeks in each of the 2 treatment periods.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postherpetic Neuralgia, Neuralgia, Herpes Zoster
    Keywords
    pain following the healing of rashes and blisters, herpes virus, rash, varicella-zoster virus, shingles.

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    91 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    002
    Arm Type
    Placebo Comparator
    Arm Description
    placebo twice daily for 4 weeks
    Arm Title
    001
    Arm Type
    Experimental
    Arm Description
    carisbamate 200 mg tablet twice daily for 4 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    twice daily for 4 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    carisbamate
    Intervention Description
    200 mg tablet twice daily for 4 weeks
    Primary Outcome Measure Information:
    Title
    The mean of the last 7 average daily PHN scores of the first treatment period on days when study drug is taken.
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    The means of the last 7 average daily PHN pain scores with no use of rescue medication, the last 7 current daily PHN pain scores, the last 7 maximum daily PHN pain scores and the last 7 daily sleep interference scores.
    Time Frame
    4 weeks (2 four-week treatment periods (cross-over design )

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of postherpetic neuralgia (PHN) with a history of varicella-zoster rash (shingles), persistent pain for at least 6 months after the healing of the rash Experienced postherpetic neuralgia pain on a daily basis for the past 3 months Women must be postmenopausal for at least 2 years, sexually abstinent, or if sexually active, be practicing an effective method of birth control, and have a negative serum pregnancy test at screening. Exclusion Criteria: History of a poor response to 3 or more medications for postherpetic neuralgia (PHN), with poor response defined as treatment with medications in the following categories of therapy for at least 1 month at therapeutic dosages without at least moderate improvement, as judged by the study doctor: Antiepileptic drugs, antidepressants, serotonin norepinephrine uptake inhibitors (SNRIs), opioid analgesics, or lidocaine patch currently taking tricyclic antidepressants, Coumadin (warfarin), or continued treatment with an antiepileptic drug for any indication, Note: If taking these medications, to be eligible for the study, they must be tapered and discontinued past neurolytic treatment (destruction of nerves by the application of chemicals, heat or cold, neurosurgery, intrathecal pumps, or spinal cord stimulators for PHN pain currently using herbal topical creams or ointments for pain relief within 48 hours, capsaicin within 6 months, or systemic corticosteroids within 3 months of the baseline period Prior exposure to RWJ-333369 (carisbamate).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
    Organizational Affiliation
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    An Effectiveness and Safety Study With RWJ-333369 (Carisbamate) for the Study of Postherpetic Neuralgia (PHN).

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