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Phase 3 Study of DW-330SR2 and Pelubiprofen in Chronic Back Pain Patients

Primary Purpose

Chronic Back Pain

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
DW-330SR2
Pelubiprofen
Sponsored by
Daewon Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Back Pain

Eligibility Criteria

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

Inclusion Criteria:

  • More than 12 weeks by the time the trial started , and low back pain that requires analgesia administration.
  • Class 1 or 2 back pain patients along Quebec Task Force Classification
  • Patients with pain at least 40mm test results at visit2
  • The voluntary or legal guardian 's written consent to participate in this clinical trial subjects

Exclusion Criteria:

  • Severe gastrointestinal disease, heart disease, high blood pressure patients
  • Patients with secondary causes are obvious
  • Within 24 weeks patient who has back surgery before clinical trial participation
  • Within 4 weeks patient who experienced psychotropic drugs, a narcotic analgesic dosage that may affect the pain sensation
  • Within 4 weeks patient who treated steroid drug by oral or injection
  • Within 2 weeks patient who treated MAO inhibition drugs
  • Patients with severe respiratory depression status

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    DW-330SR2

    Pelubiprofen

    Arm Description

    DW-330SR(Pelubiprofen) 45mg twice a day

    Active Comparator(Pelubiprofen) 30mg three times a day

    Outcomes

    Primary Outcome Measures

    The change of 100 mm Pain VAS

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2015
    Last Updated
    October 7, 2016
    Sponsor
    Daewon Pharmaceutical Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02375633
    Brief Title
    Phase 3 Study of DW-330SR2 and Pelubiprofen in Chronic Back Pain Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2014 (undefined)
    Primary Completion Date
    November 2014 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Daewon Pharmaceutical Co., Ltd.

    4. Oversight

    5. Study Description

    Brief Summary
    A Multicenter, Randomized, Double-blinded, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW-330SR2 and Pelubiprofen in Chronic Back Pain Patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Back Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    166 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    DW-330SR2
    Arm Type
    Experimental
    Arm Description
    DW-330SR(Pelubiprofen) 45mg twice a day
    Arm Title
    Pelubiprofen
    Arm Type
    Active Comparator
    Arm Description
    Active Comparator(Pelubiprofen) 30mg three times a day
    Intervention Type
    Drug
    Intervention Name(s)
    DW-330SR2
    Intervention Type
    Drug
    Intervention Name(s)
    Pelubiprofen
    Primary Outcome Measure Information:
    Title
    The change of 100 mm Pain VAS
    Time Frame
    28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: More than 12 weeks by the time the trial started , and low back pain that requires analgesia administration. Class 1 or 2 back pain patients along Quebec Task Force Classification Patients with pain at least 40mm test results at visit2 The voluntary or legal guardian 's written consent to participate in this clinical trial subjects Exclusion Criteria: Severe gastrointestinal disease, heart disease, high blood pressure patients Patients with secondary causes are obvious Within 24 weeks patient who has back surgery before clinical trial participation Within 4 weeks patient who experienced psychotropic drugs, a narcotic analgesic dosage that may affect the pain sensation Within 4 weeks patient who treated steroid drug by oral or injection Within 2 weeks patient who treated MAO inhibition drugs Patients with severe respiratory depression status

    12. IPD Sharing Statement

    Learn more about this trial

    Phase 3 Study of DW-330SR2 and Pelubiprofen in Chronic Back Pain Patients

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