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Evaluate the Efficacy and Safety of DWP05195 in Subjects With Post-Herpetic Neuralgia

Primary Purpose

Postherpetic Neuralgia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
DWP05195
DWP05195
DWP05195
Control
Sponsored by
Daewoong Pharmaceutical Co. LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postherpetic Neuralgia

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or Female subjects aged 20 to 80 years
  • Subjects with symptoms of neuropathic pain associated with postherpetic neuralgia(PHN).
  • Subjects must have pain present for > 3 months after healing of the acute herpes zoster skin rash.

Exclusion Criteria:

  • Other severe pain that may potentially confound pain assessment.
  • Subjects with symptoms of neuropathic pain applied Medical Equipment
  • Within 2 years: Subjects were diagnosed with cancer

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Treatment A

    Treatment B

    Treatment C

    Treatment D

    Arm Description

    Outcomes

    Primary Outcome Measures

    Endpoint change from the baseline after administered 8 weeks mean pain score based on the Numerical pain Rating Scale(NPRS) from the subject's daily pain diary

    Secondary Outcome Measures

    Full Information

    First Posted
    March 14, 2012
    Last Updated
    February 19, 2014
    Sponsor
    Daewoong Pharmaceutical Co. LTD.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01557010
    Brief Title
    Evaluate the Efficacy and Safety of DWP05195 in Subjects With Post-Herpetic Neuralgia
    Official Title
    The Clinical Trial for Evaluation of Efficacy and Safety of DWP05195 in Postherpetic Neuralgia: Double-blind, Placebo-controlled, Randomized, Multi-center, Exploratory Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2012 (undefined)
    Primary Completion Date
    November 2013 (Actual)
    Study Completion Date
    December 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Daewoong Pharmaceutical Co. LTD.

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate efficacy, safety of administered DWP05195 in Postherpetic Neuralgia.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment A
    Arm Type
    Experimental
    Arm Title
    Treatment B
    Arm Type
    Experimental
    Arm Title
    Treatment C
    Arm Type
    Experimental
    Arm Title
    Treatment D
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    DWP05195
    Intervention Description
    Tablets, oral administration, 100mg
    Intervention Type
    Drug
    Intervention Name(s)
    DWP05195
    Intervention Description
    Tablets, oral administration, 200mg
    Intervention Type
    Drug
    Intervention Name(s)
    DWP05195
    Intervention Description
    Tablets, oral administration, 300mg
    Intervention Type
    Drug
    Intervention Name(s)
    Control
    Intervention Description
    Tablets, oral administration, Placebo
    Primary Outcome Measure Information:
    Title
    Endpoint change from the baseline after administered 8 weeks mean pain score based on the Numerical pain Rating Scale(NPRS) from the subject's daily pain diary
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or Female subjects aged 20 to 80 years Subjects with symptoms of neuropathic pain associated with postherpetic neuralgia(PHN). Subjects must have pain present for > 3 months after healing of the acute herpes zoster skin rash. Exclusion Criteria: Other severe pain that may potentially confound pain assessment. Subjects with symptoms of neuropathic pain applied Medical Equipment Within 2 years: Subjects were diagnosed with cancer

    12. IPD Sharing Statement

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    Evaluate the Efficacy and Safety of DWP05195 in Subjects With Post-Herpetic Neuralgia

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