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Clinical Trial Name - Study of MK0663 in Patients With Chronic Low Back Pain
| Original Study ID : 2004_003 |
| NCT ID : NCT00090181 |
| Brief Title : Study of MK0663 in Patients With Chronic Low Back Pain |
| 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 |
| Brief 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. |
| Source : Merck |
| Overall Status : Completed |
| Start Date : June 2004 |
| Official Title : Phase 4 |
| Phase : Interventional |
| Study Design : Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Enrollment : 400 |
| Verification Date : September 2006 |
| First Received Date : August 25, 2004 |
| Trial Eligibility |
| 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. |
| Gender : Both |
| Minimum Age : 18 Years |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : Call for International Site Information |
| City : Horsham |
| State : Pennsylvania |
| Zip Code : 19044 |
| Country : United States |
| Refferances |
| PMID : 16368055 |
| Citation : 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. |
| OutComes |
| Primary OutComes |
| Secondary OutComes |
| Measure : Disability questionnaire |
| Measure : Patient global assessment of response to therapy |
| Interventions |
| Type : Drug |
| Name : MK0663, etoricoxib / Duration of Treatment: 4 weeks |
| Type : Drug |
| Name : Comparator: diclofenac / Duration of Treatment: 4 weeks |
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