Status:
TERMINATED
Study To Investigate The Effectiveness Of Pregabalin For Management Of Patients Undergoing Total Hip Replacement
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Pain, Perioperative
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is the investigate if pregabalin started a day before surgery and continued for 14 days post-operatively can reduce post-operative pain, relieve pre- and post-operative anxie...
Eligibility Criteria
Inclusion
- The patient is undergoing a routine (i.e., expected to be uncomplicated) total primary or secondary hip replacement surgery performed under a standardized regimen of spinal anesthesia, and is expected to experience moderate to severe post-surgical pain in the absence of post-operative analgesia
Exclusion
- The patient is undergoing a revision to a previous hip replacement procedure, hip replacement procedure further to a road traffic accident with multiple injuries, or a procedure expected to last longer than 4 hours
- The patient has a history of uncontrolled chronic disease or a concurrent clinically significant illness or medical condition, which in the Investigator's opinion, would contraindicate study participation or confound interpretation of the results
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00905437
Start Date
November 1 2009
End Date
July 1 2012
Last Update
January 28 2021
Active Locations (7)
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1
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, India, 500 033
2
Pfizer Investigational Site
Ahmedabad, Gujarat, India, 380 015
3
Pfizer Investigational Site
Bangalore, Karnataka, India, 560 076
4
Pfizer Investigational Site
Kanpur, Uttar Pradesh, India, 208 001