Effect of Etoricoxib to Treat Chronic Low Back Pain

Original Study ID : 2006_547

Secondary ID : MK0663-042

NCT ID : NCT00393211

Brief Title : Effect of Etoricoxib to Treat Chronic Low Back Pain

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

Brief Summary :

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

Source : Merck

Overall Status : Completed

Start Date : April 2000

Official Title : Phase 3

Phase : Interventional

Study Design : Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Enrollment : 300

Verification Date : May 2009

First Received Date : October 26, 2006

Trial Eligibility

Criteria :
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

Gender : Both

Minimum Age : 18 Years

Maximum Age : 75 Years

Healthy Volunteers : No

Refferances

PMID : 14622687

Citation : 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.

PMID : 14996519

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.

PMID : 18317199

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. 2008 Mar 1;33(5):533-8.

OutComes

Primary OutComes

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

Secondary OutComes

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

Interventions

Type : Drug

Name : MK0663, Etoricoxib / Duration of Treatment : 12 Weeks

Type : Drug

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

Clinical Trial Name - Effect of Etoricoxib to Treat Chronic Low Back Pain