Efficacy And Safety Of Pregabalin For Pain Following Total Knee Replacement

Completed · Phase 3 · Has a placebo group

Conditions studied: Osteoarthritis, Postoperative Pain

In brief

Pregabalin added to the standard of care with dosing starting preoperatively and continuing for up to 6 weeks post surgery will decrease the intensity of post-operative pain following total knee replacement.

Key facts

Study ID

NCT00442546

Run by

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

People needed

307

Starts

2007-05-01

Expected to finish

2008-12-01

Last updated by the study team

2021-01-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with osteoarthritis (OA) undergoing elective TKA under regional anesthesia (neuroaxial with or without peripheral nerve block).
• Subjects able to demonstrate sufficient psychomotor dexterity and cognitive capacity to use Patient Controlled Analgesia/Patient Controlled Epidural Analgesia if used as part of the standard of care.
• The subject's preoperative health is graded as American Society of Anesthesiology Class 1 to Class 3

You may not qualify if…

• Subjects undergoing revision, unicompartmental, bilateral total knee arthroplasty or subjects with planned second knee total knee arthroplasty at time of present procedure.
• Subjects with inflammatory arthritides (i.e., rheumatoid arthritis, lupus, ankylosing spondylitis, psoriatic arthritis); Lyme disease.
• Subjects with fibromyalgia and or other chronic pain syndromes

Where it is running

• Pfizer Investigational Site — Northport, Alabama, United States
• Pfizer Investigational Site — Tuscaloosa, Alabama, United States
• Pfizer Investigational Site — Tuscaloosa, Alabama, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Little Rock, Arkansas, United States
• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — Vero Beach, Florida, United States
• Pfizer Investigational Site — Chicago, Illinois, United States
• Pfizer Investigational Site — Galesburg, Illinois, United States
• Pfizer Investigational Site — Lafayette, Louisiana, United States
• Pfizer Investigational Site — New Iberia, Louisiana, United States
• Pfizer Investigational Site — Baltimore, Maryland, United States
• Pfizer Investigational Site — Egg Harbor, New Jersey, United States
• Pfizer Investigational Site — Pomona, New Jersey, United States
• Pfizer Investigational Site — Voorhees Township, New Jersey, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — Charlotte, North Carolina, United States
• Pfizer Investigational Site — Columbus, Ohio, United States
• Pfizer Investigational Site — Columbus, Ohio, United States
• Pfizer Investigational Site — Upper Arlington, Ohio, United States
• Pfizer Investigational Site — Allentown, Pennsylvania, United States
• Pfizer Investigational Site — King of Prussia, Pennsylvania, United States
• Pfizer Investigational Site — Philadelphia, Pennsylvania, United States
• Pfizer Investigational Site — Pittsburgh, Pennsylvania, United States
• Pfizer Investigational Site — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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