Effect of Etoricoxib to Treat Chronic Low Back Pain (0663-042)
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
About this trial
This is an interventional treatment trial for Recurrent Low Back Pain
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 an 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
1. Study Identification
Unique Protocol Identification Number
NCT00393211
Brief Title
Effect of Etoricoxib to Treat Chronic Low Back Pain (0663-042)
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
319 (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 an 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
14622687
Citation
Birbara CA, Puopolo AD, Munoz DR, Sheldon EA, Mangione A, Bohidar NR, Geba GP; Etoricoxib Protocol 042 Study Group. Treatment of chronic low back pain with etoricoxib, a new cyclo-oxygenase-2 selective inhibitor: improvement in pain and disability--a randomized, placebo-controlled, 3-month trial. J Pain. 2003 Aug;4(6):307-15. doi: 10.1016/s1526-5900(03)00633-3.
Results Reference
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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
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Effect of Etoricoxib to Treat Chronic Low Back Pain (0663-042)
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