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NCT00090181 Clinical Trial

Study of MK0663 in Patients With Chronic Low Back Pain (0663-806)(COMPLETED)

Chronic Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00090181
Other study ID # 0663-806
Secondary ID 2004_003
Status Completed
Phase Phase 4
First received
Last updated
Start date June 2004
Est. completion date March 2005

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 401
Est. completion date March 2005
Est. primary completion date March 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0663, etoricoxib / Duration of Treatment: 4 weeks

• Comparator: diclofenac / Duration of Treatment: 4 weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

References & Publications (1)

Zerbini C, Ozturk ZE, Grifka J, Maini M, Nilganuwong S, Morales R, Hupli M, Shivaprakash M, Giezek H; 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Lower back pain intensity
Primary Safety and tolerability
Secondary Disability questionnaire
Secondary Patient global assessment of response to therapy
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