Effect of Etoricoxib to Treat Chronic Low Back Pain (0663-042)

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00393211
• Other study ID #: 0663-042
• Secondary ID: 2006_547
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Recurrent Low Back Pain

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