Effect of Etoricoxib to Treat Chronic Low Back Pain

Original Study ID : 2006_548

Secondary ID : MK0663-041

NCT ID : NCT00393354

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 MK0663 study

Gender : Both

Minimum Age : 18 Years

Maximum Age : 75 Years

Healthy Volunteers : No

Refferances

PMID : 15370723

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.

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