Study of MK0663 in Patients With Chronic Low Back Pain

Condition(s) targeted: Chronic Low Back Pain

Intervention: MK0663, etoricoxib / Duration of Treatment: 4 weeks (Drug); Comparator: diclofenac / Duration of Treatment: 4 weeks (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Merck

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck

The purpose of this study is to evaluate the efficacy of MK0663 for the treatment of chronic low back pain and to investigate the overall safety and tolerability over four weeks of treatment.

Official title: A Double-Blind, Parallel-Group, 4-Week Trial to Assess the Efficacy and Safety of Etoricoxib 60 Mg and Diclofenac 150 Mg in Patients With Chronic Low Back Pain

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Lower back pain intensity

Safety and tolerability

Secondary outcome:

Disability questionnaire

Patient global assessment of response to therapy

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male and female patients 18 years of age or older, who have Chronic Low Back Pain

after the discontinuation of their previous medication for their condition.

- Patients should have at least 3 months of Low Back Pain.

Call for International Site Information, Horsham, Pennsylvania 19044, United States

Related publications:

Zerbini C, Ozturk ZE, Grifka J, Maini M, Nilganuwong S, Morales R, Hupli M, Shivaprakash M, Giezek H; The Etoricoxib CLBP Study Group. Efficacy of etoricoxib 60 mg/day and diclofenac 150 mg/day in reduction of pain and disability in patients with chronic low back pain: results of a 4-week, multinational, randomized, double-blind study. Curr Med Res Opin. 2005 Dec;21(12):2037-49.

Starting date: June 2004
Last updated: September 5, 2006