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

Phase 3

Completed

• Conditions: Recurrent Low Back Pain

• Registration Number: NCT00393354
• Lead Sponsor: Organon and Co

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2000-04
• Primary Completion: 2000-11
• Study Completion: 2000-11
• Study First Submitted: 2006-10-26
• Study First Submitted QC: 2006-10-26
• Study First Posted: 2006-10-27
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 325

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Low back pain intensity scale (0-100 mm VAS) over 4 weeks compared to placebo

Secondary Outcome Measures

Name	Time	Method
Low back pain intensity scale (0-100 mm VAS) over 12 weeks compared to placebo