Efficacy And Safety Of Pregabalin For Pain Following Total Knee Replacement

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NCT00442546

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Study Location
Pfizer Investigational Site
Northport, Alabama, 35476, United States
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Contact
1-800-718-1021
[email protected]
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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis, Postoperative Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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


- 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

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Osteoarthritis, Postoperative PainEfficacy And Safety Of Pregabalin For Pain Following Total Knee Replacement
NCT00442546
  1. Northport, Alabama
  2. Tuscaloosa, Alabama
  3. Tuscaloosa, Alabama
  4. Phoenix, Arizona
  5. Little Rock, Arkansas
  6. Miami, Florida
  7. Vero Beach, Florida
  8. Chicago, Illinois
  9. Galesburg, Illinois
  10. Lafayette, Louisiana
  11. New Iberia, Louisiana
  12. Baltimore, Maryland
  13. Egg Harbor Township, New Jersey
  14. Pomona, New Jersey
  15. Voorhees, New Jersey
  16. New York, New York
  17. Charlotte, North Carolina
  18. Columbus, Ohio
  19. Columbus, Ohio
  20. Upper Arlington, Ohio
  21. Allentown, Pennsylvania
  22. King Of Prussia, Pennsylvania
  23. Philadelphia, Pennsylvania
  24. Pittsburgh, Pennsylvania
  25. Pittsburgh, Pennsylvania
  26. Dallas, Texas
  27. Houston, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy And Safety Of Pregabalin For Pain Following Total Knee Replacement
Official Title  ICMJE A Multicenter, Double-Blind Randomized, Placebo-Controlled Study Of The Efficacy And Safety Of Pregabalin In The Treatment Of Subjects With Post-Operative Pain Following Total Knee Arthroplasty (TKA)
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 replacement.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis
  • Postoperative Pain
Intervention  ICMJE
  • Drug: pregabalin
    150 milligram (mg)/ day (double blind)
  • Drug: pregabalin
    300 mg/day (double blind)
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: pregabalin
  • Experimental: 2
    Intervention: Drug: pregabalin
  • Placebo Comparator: 3
    Intervention: Drug: Placebo
Publications * Singla NK, Chelly JE, Lionberger DR, Gimbel J, Sanin L, Sporn J, Yang R, Cheung R, Knapp L, Parsons B. Pregabalin for the treatment of postoperative pain: results from three controlled trials using different surgical models. J Pain Res. 2014 Dec 23;8:9-20. doi: 10.2147/JPR.S67841. eCollection 2015.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 9, 2009)		307
Original Enrollment  ICMJE
 (submitted: March 1, 2007)		300
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00442546
Other Study ID Numbers  ICMJE A0081133
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP