Study Stopped
This study was terminated early due to slow enrollment.
Celebrex Total Knee Arthroplasty Study
Multicenter, Double Blind, Randomized, Placebo Controlled Trial Of The Efficacy And Safety Of Usual Care Plus Celecoxib Compared To Placebo For Peri-Operative And Rehabilitation Pain Control And Return To Function In Osteoarthritis Patients Undergoing Total Knee Arthroplasty
1 other identifier
interventional
22
1 country
7
Brief Summary
This study will investigate the benefits of administering celecoxib (Celebrex), a selective cyclooxygenase -2 (COX-2) inhibitor, in treating osteoarthritis (OA) subjects undergoing elective unilateral primary total knee arthroplasty (TKA) from the pre-operative phase to the management of post total knee replacement pain, and through the 6 weeks of physical therapy and rehabilitation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Nov 2006
Shorter than P25 for phase_4
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2006
CompletedFirst Posted
Study publicly available on registry
August 1, 2006
CompletedStudy Start
First participant enrolled
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedMarch 3, 2021
March 1, 2021
July 28, 2006
March 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the effects of celecoxib on the cumulative amount of opioid administered to OA subjects undergoing unilateral total knee arthroplasty.
19 July 2007
Secondary Outcomes (2)
To assess the effects of celecoxib on pain and function during the peri-operative period and the post-operative rehabilitation phase.
19 July 2007
To assess the safety and tolerability of celecoxib in this study population.
19 July 2007
Study Arms (2)
Celecoxib
EXPERIMENTALCelecoxib
Placebo
PLACEBO COMPARATORPlacebo
Interventions
7 days pre-surgery (excluding day of surgery): 1 celecoxib 200 mg capsule or matching placebo QD; Day of surgery: 2 celecoxib 200 mg capsules or matching placebo within 2 hours prior to surgery, and 1 celecoxib 200 mg capsule or matching placebo following surgery; Post-surgery: starting the day after surgery, 1 celecoxib 200 mg capsule or matching placebo BID for the duration of the study.
Placebo once daily (QD) for 7 days pre-surgery (excluding the day of surgery); Placebo within 2 hours prior to surgery; and post surgery on the same day of the surgery; Placebo twice daily (BID) following the day of surgery and for the duration of the study.
Eligibility Criteria
You may qualify if:
- The subject is a male or female 18 years or older with osteoarthritis of the knee scheduled to undergo elective unilateral primary total knee arthroplasty because of OA, performed under a standardized regimen of anesthesia and procedure.
You may not qualify if:
- Subject has a history of inflammatory arthritis (e.g. rheumatoid arthritis, ankylosing spondylitis) other than osteoarthritis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Pfizer Investigational Site
Aurora, Colorado, 80012, United States
Pfizer Investigational Site
Englewood, Colorado, 80110, United States
Pfizer Investigational Site
Chicago, Illinois, 60612, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19107, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19140, United States
Pfizer Investigational Site
Bellaire, Texas, 77410, United States
Pfizer Investigational Site
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2006
First Posted
August 1, 2006
Study Start
November 1, 2006
Study Completion
July 1, 2007
Last Updated
March 3, 2021
Record last verified: 2021-03