Back to resultsA Study of Rofecoxib in the Treatment of Post-Operative Pain After Total Knee Joint Replacement (0966-259)
Primary Purpose
Pain
Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
MK0966; rofecoxib
Comparator: diclofenac 2x 75 mg
Sponsored by
About this trial
This is an interventional treatment trial for Pain
Eligibility Criteria
Inclusion Criteria: Males or females at least 18 years of age who have osteoarthritis of the knee and have undergone total knee joint replacement.
Sites / Locations
Outcomes
Primary Outcome Measures
Quantity of patient controlled
Post-operative morphine administration
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00140920
Brief Title
A Study of Rofecoxib in the Treatment of Post-Operative Pain After Total Knee Joint Replacement (0966-259)
Official Title
A Study to Compare Pre-Operative Administration of Rofecoxib Vs Post-Operative Administration of Diclofenac or Rofecoxib in the Treatment of Post-Operative Pain After Total Knee Joint Replacement in Patients With Osteoarthritis of the Knee.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Recruitment/study discontinued after withdrawal of marketing authorisation. No data entered.
Study Start Date
May 25, 2004 (Actual)
Primary Completion Date
September 27, 2004 (Actual)
Study Completion Date
September 27, 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
A study to compare pre-operative administration of rofecoxib versus post-operative administration of diclofenac or rofecoxib, respectively, in the treatment of post-operative pain after total knee joint replacement in patients with osteoarthritis of the knee.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0966; rofecoxib
Intervention Type
Drug
Intervention Name(s)
Comparator: diclofenac 2x 75 mg
Primary Outcome Measure Information:
Title
Quantity of patient controlled
Title
Post-operative morphine administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males or females at least 18 years of age who have osteoarthritis of the knee and have undergone total knee joint replacement.
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
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
A Study of Rofecoxib in the Treatment of Post-Operative Pain After Total Knee Joint Replacement (0966-259)
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