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Effect of Etoricoxib to Treat Chronic Low Back Pain (0663-041)

Primary Purpose

Recurrent Low Back Pain

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0663, Etoricoxib / Duration of Treatment : 12 Weeks
Comparator : placebo (unspecified) /Duration of Treatment : 12 Weeks
Sponsored by
Organon and Co
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Low Back Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Low back pain for previous 3 months and majority of days in last month
  • Regular use of acetaminophen or NSAID to treat low back pain in past month
  • Judged to be in otherwise good health

Exclusion Criteria:

  • Low back pain that is due to secondary causes
  • Radicular/myelopathic pain
  • Surgery for low back pain within the past 6 months
  • Active lawsuit or claim pertaining to their low back pain
  • Disease that may confound the results of the study or pose risk to the patients
  • Corticosteroid use in past month
  • Previous participation in MK0663 study

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Low back pain intensity scale (0-100 mm VAS) over 4 weeks compared to placebo

    Secondary Outcome Measures

    Low back pain intensity scale (0-100 mm VAS) over 12 weeks compared to placebo

    Full Information

    First Posted
    October 26, 2006
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00393354
    Brief Title
    Effect of Etoricoxib to Treat Chronic Low Back Pain (0663-041)
    Official Title
    A Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Trial to Assess the Efficacy and Safety of MK0663 in Patients With Chronic Low Back Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2000 (undefined)
    Primary Completion Date
    November 2000 (Actual)
    Study Completion Date
    November 2000 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    5. Study Description

    Brief Summary
    Study the effect of etoricoxib 60 mg and 90 mg compared to placebo to treat chronic low back pain.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    325 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0663, Etoricoxib / Duration of Treatment : 12 Weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator : placebo (unspecified) /Duration of Treatment : 12 Weeks
    Primary Outcome Measure Information:
    Title
    Low back pain intensity scale (0-100 mm VAS) over 4 weeks compared to placebo
    Secondary Outcome Measure Information:
    Title
    Low back pain intensity scale (0-100 mm VAS) over 12 weeks compared to placebo

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Low back pain for previous 3 months and majority of days in last month Regular use of acetaminophen or NSAID to treat low back pain in past month Judged to be in otherwise good health Exclusion Criteria: Low back pain that is due to secondary causes Radicular/myelopathic pain Surgery for low back pain within the past 6 months Active lawsuit or claim pertaining to their low back pain Disease that may confound the results of the study or pose risk to the patients Corticosteroid use in past month Previous participation in MK0663 study
    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

    Citations:
    PubMed Identifier
    15370723
    Citation
    Pallay RM, Seger W, Adler JL, Ettlinger RE, Quaidoo EA, Lipetz R, O'Brien K, Mucciola L, Skalky CS, Petruschke RA, Bohidar NR, Geba GP. Etoricoxib reduced pain and disability and improved quality of life in patients with chronic low back pain: a 3 month, randomized, controlled trial. Scand J Rheumatol. 2004;33(4):257-66. doi: 10.1080/03009740410005728.
    Results Reference
    background
    PubMed Identifier
    14996519
    Citation
    Curtis SP, Ng J, Yu Q, Shingo S, Bergman G, McCormick CL, Reicin AS. Renal effects of etoricoxib and comparator nonsteroidal anti-inflammatory drugs in controlled clinical trials. Clin Ther. 2004 Jan;26(1):70-83. doi: 10.1016/s0149-2918(04)90007-0.
    Results Reference
    background
    PubMed Identifier
    18317199
    Citation
    Sheldon EA, Bird SR, Smugar SS, Tershakovec AM. Correlation of measures of pain, function, and overall response: results pooled from two identical studies of etoricoxib in chronic low back pain. Spine (Phila Pa 1976). 2008 Mar 1;33(5):533-8. doi: 10.1097/BRS.0b013e3181657d24.
    Results Reference
    background

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    Effect of Etoricoxib to Treat Chronic Low Back Pain (0663-041)

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