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Efficacy And Safety Of Pregabalin For Pain Following Total Knee Replacement

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Northport, Alabama, 35476 United States
Contact
1-800-718-1021
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

NCT00442546
Pfizer
Completed
Efficacy And Safety Of Pregabalin For Pain Following Total Knee Replacement

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Efficacy And Safety Of Pregabalin For Pain Following Total Knee Replacement
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)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Osteoarthritis
  • Postoperative Pain
  • Drug: pregabalin
    150 milligram (mg)/ day (double blind)
  • Drug: pregabalin
    300 mg/day (double blind)
  • Drug: Placebo
    Placebo
  • Experimental: 1
    Intervention: Drug: pregabalin
  • Experimental: 2
    Intervention: Drug: pregabalin
  • Placebo Comparator: 3
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
307
December 2008
December 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00442546
A0081133
Yes
Not Provided
Not Provided
Clinical Trials Disclosure Group, Pfizer, Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2011

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.

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1-800-718-1021

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Contact

[email protected]



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