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Safety and Preliminary Efficacy of MK0759 in Postherpetic Neuralgia (PHN)(0759-004)

Primary Purpose

Neuralgia, Postherpetic

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0759
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuralgia, Postherpetic

Eligibility Criteria

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

Inclusion Criteria: Age 18 to 85; diagnosis of postherpetic neuralgia with pain having persisted at least 6 months; dissatisfied with current regimen of pain control; able to complete study questionnaires, patient diary, and comply with daily study medication Exclusion Criteria: Women of childbearing potential; history or evidence of a condition that, in the opinion of the investigator, may interfere with the study interpretation (e.g., diabetic neuropathy or fibromyalgia) or pose undue risk to undergo the course of medication required by the study (e.g., unstable heart disease, morbid obesity, kidney or liver disease).

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Pain intensity recorded by the patient each evening using an 11-point Likert scale (0=no pain to 10=pain as bad as you can imagine).

    Secondary Outcome Measures

    Safety; Patient Global Impression of Change assessed at the end of each treatment period.

    Full Information

    First Posted
    October 26, 2005
    Last Updated
    May 20, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00245544
    Brief Title
    Safety and Preliminary Efficacy of MK0759 in Postherpetic Neuralgia (PHN)(0759-004)
    Official Title
    A Randomized, Double-Blind, Placebo-Controlled, Two-Period Crossover Study to Explore the Safety and Preliminary Efficacy of Oral MK0759 in the Treatment of Postherpetic Neuralgia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Terminated
    Study Start Date
    November 2005 (undefined)
    Primary Completion Date
    January 2007 (Actual)
    Study Completion Date
    January 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to test the safety and effect of MK0759 in relieving neuropathic pain as experienced by patients with postherpetic neuralgia (PHN).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neuralgia, Postherpetic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0759
    Primary Outcome Measure Information:
    Title
    Pain intensity recorded by the patient each evening using an 11-point Likert scale (0=no pain to 10=pain as bad as you can imagine).
    Time Frame
    Duration of Treatment
    Secondary Outcome Measure Information:
    Title
    Safety; Patient Global Impression of Change assessed at the end of each treatment period.
    Time Frame
    Duration of Treatment

    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: Age 18 to 85; diagnosis of postherpetic neuralgia with pain having persisted at least 6 months; dissatisfied with current regimen of pain control; able to complete study questionnaires, patient diary, and comply with daily study medication Exclusion Criteria: Women of childbearing potential; history or evidence of a condition that, in the opinion of the investigator, may interfere with the study interpretation (e.g., diabetic neuropathy or fibromyalgia) or pose undue risk to undergo the course of medication required by the study (e.g., unstable heart disease, morbid obesity, kidney or liver disease).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Safety and Preliminary Efficacy of MK0759 in Postherpetic Neuralgia (PHN)(0759-004)

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