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

NCT00393211 | Completed Phase 3

• 2 other identifiers: 0663-0422006_547
• Study Type: interventional
• Target: 319
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Recurrent Low Back Pain

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

MK0663, Etoricoxib / Duration of Treatment : 12 Weeks DRUG

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related 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. doi: 10.1016/s1526-5900(03)00633-3.

  PMID: 14622687 BACKGROUND

• 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.

  PMID: 14996519 BACKGROUND

• 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.

  PMID: 18317199 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Etoricoxib; Duration of Therapy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2006
• First Posted: October 27, 2006
• Study Start: April 1, 2000
• Primary Completion: November 1, 2000
• Study Completion: November 1, 2000
• Last Updated: February 18, 2022

Record last verified: 2022-02