Back to resultsStudy of MK0663 in Patients With Chronic Low Back Pain (0663-806)(COMPLETED)
Primary Purpose
Chronic Low Back Pain
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
MK0663, etoricoxib / Duration of Treatment: 4 weeks
Comparator: diclofenac / Duration of Treatment: 4 weeks
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Arcoxia
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Lower back pain intensity
Safety and tolerability
Secondary Outcome Measures
Disability questionnaire
Patient global assessment of response to therapy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00090181
Brief Title
Study of MK0663 in Patients With Chronic Low Back Pain (0663-806)(COMPLETED)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Arcoxia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
401 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0663, etoricoxib / Duration of Treatment: 4 weeks
Intervention Type
Drug
Intervention Name(s)
Comparator: diclofenac / Duration of Treatment: 4 weeks
Primary Outcome Measure Information:
Title
Lower back pain intensity
Title
Safety and tolerability
Secondary Outcome Measure Information:
Title
Disability questionnaire
Title
Patient global assessment of response to therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
16368055
Citation
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. doi: 10.1185/030079905X75069.
Results Reference
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Learn more about this trial
Study of MK0663 in Patients With Chronic Low Back Pain (0663-806)(COMPLETED)
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