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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00393211
Other study ID # 0663-042
Secondary ID 2006_547
Status Completed
Phase Phase 3
First received
Last updated
Start date April 2000
Est. completion date November 2000

Study information

Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
MK0663, Etoricoxib / Duration of Treatment : 12 Weeks

Comparator : placebo (unspecified) /Duration of Treatment : 12 Weeks


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Organon and Co

References & Publications (3)

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

Outcome

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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