Status:
COMPLETED
Efficacy And Safety Of Pregabalin For Pain Following Total Knee Replacement
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Osteoarthritis
Postoperative Pain
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
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 repla...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
307 Patients enrolled
Trial Details
Trial ID
NCT00442546
Start Date
May 1 2007
End Date
December 1 2008
Last Update
January 22 2021
Active Locations (27)
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1
Pfizer Investigational Site
Northport, Alabama, United States, 35476
2
Pfizer Investigational Site
Tuscaloosa, Alabama, United States, 35401
3
Pfizer Investigational Site
Tuscaloosa, Alabama, United States, 35406
4
Pfizer Investigational Site
Phoenix, Arizona, United States, 85023