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

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

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

Study Overview

• Status: Completed
• Conditions: Recurrent Low Back Pain
• Intervention / Treatment: Drug: MK0663, Etoricoxib / Duration of Treatment : 12 Weeks; Drug: Comparator : placebo (unspecified) /Duration of Treatment : 12 Weeks

• Study Type: Interventional
• Enrollment (Actual): 325
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Low back pain intensity scale (0-100 mm VAS) over 4 weeks compared to placebo

Secondary Outcome Measures

Outcome Measure
Low back pain intensity scale (0-100 mm VAS) over 12 weeks compared to placebo

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General Publications

• 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. doi: 10.1016/s0149-2918(04)90007-0.
• 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.
• 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. doi: 10.1080/03009740410005728.

Study record dates

Study Major Dates

• Study Start: April 1, 2000
• Primary Completion (Actual): November 1, 2000
• Study Completion (Actual): November 1, 2000

Study Registration Dates

• First Submitted: October 26, 2006
• First Submitted That Met QC Criteria: October 26, 2006
• First Posted (Estimate): October 27, 2006

Study Record Updates

• Last Update Posted (Actual): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Etoricoxib
• Other Study ID Numbers: 0663-041; 2006_548