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Study To Investigate The Effectiveness Of Pregabalin For Management Of Patients Undergoing Total Hip Replacement

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, 500 033 India
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Perioperative Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00905437
Pfizer
Terminated
Study To Investigate The Effectiveness Of Pregabalin For Management Of Patients Undergoing Total Hip Replacement

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Study To Investigate The Effectiveness Of Pregabalin For Management Of Patients Undergoing Total Hip Replacement
Randomized Double-Blind, Multi-Center Study Of Efficacy And Tolerability Of Pregabalin Versus Placebo As An Adjunct To Standard Of Care For Perioperative Management Of Patients Undergoing Total Hip Arthroplasty
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 anxiety and sleep disturbances.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Pain, Perioperative
  • Drug: Placebo
    Placebo as an adjunct to standard of care
  • Drug: Pregabalin
    75 mg BD for 14 days
  • Placebo Comparator: Placebo
    Placebo as an adjunct to standard of care
    Intervention: Drug: Placebo
  • Active Comparator: Pregabalin
    Pregabalin as an adjunct to standard of care
    Intervention: Drug: Pregabalin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
72
July 2012
July 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT00905437
A0081229
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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