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Clinical Trial of Pregabalin and COX2 in Spinal Stenosis

Primary Purpose

Spinal Stenosis Lumbar

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Pregabalin 75mg
Celebrex 200Mg Capsule
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Stenosis Lumbar focused on measuring Pregabalin, Selective COX-2 inhibitor

Eligibility Criteria

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

Inclusion Criteria:

  • Spinal stenosis

Exclusion Criteria:

  • Koval grade >=3
  • Other musculoskeletal disorders which cause pain on other joint
  • Bleeding risk or ulcer history
  • Severe cardiovascular, pulmonary, renal, brain, liver dysfunction

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Pregabalin and COX-2 inhibitor

    COX-2 inhibitor

    Arm Description

    Pregabalin 75mg BID + Celecoxib 200mg qd

    Celecoxib 200mg qd

    Outcomes

    Primary Outcome Measures

    Visual analog scale
    Pain score for low back and lower leg

    Secondary Outcome Measures

    Pain sensitivity questionnaire (PSQ)
    Level of pain sensitivity
    Oswestry disability index (ODI)
    The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel

    Full Information

    First Posted
    June 29, 2018
    Last Updated
    June 29, 2018
    Sponsor
    Seoul National University Bundang Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03584074
    Brief Title
    Clinical Trial of Pregabalin and COX2 in Spinal Stenosis
    Official Title
    Comparative Study for Decrease of Pain Intensity and Pain Sensitivity Between Pregabalin + COX-2 Inhibitor and COX-2 Inhibitor in Patients With Lumbar Spinal Stenosis: Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 1, 2018 (Anticipated)
    Primary Completion Date
    May 30, 2019 (Anticipated)
    Study Completion Date
    December 31, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Bundang Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Aim of this prospective, single-blind, randomized study was to compare the efficacy of the combination of celecoxib and pregabalin and celecoxib only monotherapy for treatment of chronic low-back pain.
    Detailed Description
    The efficacy and safety of the association of celecoxib [a selective cyclooxygenase-2 (COX-2) inhibitor] and pregabalin (commonly used to control neuropathic pain), compared with monotherapy of each, were evaluated for the treatment of chronic low-back pain, a condition known to be due to neuropathic as well as nociceptive pain mechanisms. We will compare the efficacy of the combination of a selective COX-2 inhibitor (celecoxib) and an antineuropathic drug, pregabalin, versus celecoxib only monotherapy, in the treatment of spinal stenosis. Each treatment lasted 8 weeks Primary outcome is mean pain reduction following different treatments regimes. Secondary outcomes are the changes of pain sensitivity, Oswestry disability index, adverse effects due to the treatments under study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Stenosis Lumbar
    Keywords
    Pregabalin, Selective COX-2 inhibitor

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pregabalin and COX-2 inhibitor
    Arm Type
    Experimental
    Arm Description
    Pregabalin 75mg BID + Celecoxib 200mg qd
    Arm Title
    COX-2 inhibitor
    Arm Type
    Active Comparator
    Arm Description
    Celecoxib 200mg qd
    Intervention Type
    Drug
    Intervention Name(s)
    Pregabalin 75mg
    Intervention Description
    Orally taken twice daily for 8 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Celebrex 200Mg Capsule
    Intervention Description
    Orally taken once daily for 8 weeks
    Primary Outcome Measure Information:
    Title
    Visual analog scale
    Description
    Pain score for low back and lower leg
    Time Frame
    At 8 weeks
    Secondary Outcome Measure Information:
    Title
    Pain sensitivity questionnaire (PSQ)
    Description
    Level of pain sensitivity
    Time Frame
    At 8 weeks
    Title
    Oswestry disability index (ODI)
    Description
    The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel
    Time Frame
    At 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Spinal stenosis Exclusion Criteria: Koval grade >=3 Other musculoskeletal disorders which cause pain on other joint Bleeding risk or ulcer history Severe cardiovascular, pulmonary, renal, brain, liver dysfunction
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ho-Joong Kim, M.D., Ph.D
    Phone
    +82317872300
    Email
    oshjkim@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Trial of Pregabalin and COX2 in Spinal Stenosis

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