Recurrent Low Back Pain Clinical Trial
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
Verified date | February 2022 |
Source | Organon and Co |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Study the effect of etoricoxib 60 mg and 90 mg compared to placebo to treat chronic low back pain.
Status | Completed |
Enrollment | 319 |
Est. completion date | November 2000 |
Est. primary completion date | November 2000 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Organon and Co |
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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Low back pain intensity scale (0-100 mm VAS) over 4 weeks compared to placebo | |||
Secondary | Low back pain intensity scale (0-100 mm VAS) over 12 weeks compared to placebo |
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