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

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: NCT00393354
• Other study ID #: 0663-041
• Secondary ID: 2006_548
• 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: 325
• 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 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)

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

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. — 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