Efficacy And Safety Of Pregabalin For Pain Following Total Knee Replacement - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00442546

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis Postoperative Pain	Drug: pregabalin Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	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)

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement Osteoarthritis Surgery

Drug Information available for: Pregabalin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

To assess the efficacy of pregabalin compared to placebo on pain following total knee arthroplasty using a subject reported assessment of worst pain. [ Time Frame: 48 hours after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Effect of pregabalin on the occurrence of opioid related symptoms [ Time Frame: Daily in hospital and then every other weekly ] [ Designated as safety issue: No ]
To evaluate the presence of neuropathic pain symptoms at 3 and 6 months post surgery [ Time Frame: 3 and 6 montns ] [ Designated as safety issue: Yes ]
Effect of pregabalin on rescue medication/opioid sparing [ Time Frame: Daily ] [ Designated as safety issue: No ]
Evaluate the effect of pregabalin at reducing post-operative pain at different time points post total knee arthroplasty [ Time Frame: Daily ] [ Designated as safety issue: No ]
To evaluate the effect of pregabalin on time to eligibility for hospital discharge and time to actual hospital discharge [ Time Frame: Daily ] [ Designated as safety issue: No ]
Evaluate the effect of pregabalin on pain interference with functional activities [ Time Frame: Baseline, Discharge, and week 2,4,6 ] [ Designated as safety issue: No ]
Evaluate safety and tolerability of pregabalin [ Time Frame: Daily in hospital and then at week 2,4,6 ] [ Designated as safety issue: Yes ]
To evaluate the effect of pregabalin on persistent post-operative pain [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
To evaluate the effect of pregabalin on pain-related sleep interference [ Time Frame: Daily ] [ Designated as safety issue: No ]
To evaluate the effect of pregabalin on treatment satisfaction with study medication [ Time Frame: Discharge and week 2,4,6 ] [ Designated as safety issue: No ]
To evaluate the effect of pregabalin on pre-operative anxiety [ Time Frame: Baseline, day of surgery, and daily in hospital ] [ Designated as safety issue: No ]

Enrollment:	307
Study Start Date:	May 2007
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: pregabalin 150 mg/ day (double blind)
2: Experimental	Drug: pregabalin 300 mg/day (double blind)
3: Placebo Comparator	Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with osteoarthritis (OA) undergoing elective total knee arthroplasty (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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442546

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Locations

United States, Alabama
Pfizer Investigational Site
Northport, Alabama, United States, 35476
Pfizer Investigational Site
Tuscaloosa, Alabama, United States, 35401
Pfizer Investigational Site
Tuscaloosa, Alabama, United States, 35406
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85023
United States, Arkansas
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 331036
Pfizer Investigational Site
Vero Beach, Florida, United States, 32960
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60612
Pfizer Investigational Site
Galesburg, Illinois, United States, 61401
United States, Louisiana
Pfizer Investigational Site
Lafayette, Louisiana, United States, 70503
Pfizer Investigational Site
New Iberia, Louisiana, United States, 70563
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21218
United States, New Jersey
Pfizer Investigational Site
Voorhees, New Jersey, United States, 08043
Pfizer Investigational Site
Egg Harbor Township, New Jersey, United States, 08234
Pfizer Investigational Site
Pomona, New Jersey, United States, 08205
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10021
United States, North Carolina
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28207
United States, Ohio
Pfizer Investigational Site
Columbus, Ohio, United States, 43214
Pfizer Investigational Site
Columbus, Ohio, United States, 43215
Pfizer Investigational Site
Upper Arlington, Ohio, United States, 43220
United States, Pennsylvania
Pfizer Investigational Site
Allentown, Pennsylvania, United States, 18103
Pfizer Investigational Site
Pittsburg, Pennsylvania, United States, 15232
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15213-2582
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15232
Pfizer Investigational Site
King of Prussia, Pennsylvania, United States, 19406
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030
Pfizer Investigational Site
Dallas, Texas, United States, 75390

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc ( Clinical Trials Disclosure Group )
Study ID Numbers:	A0081133
Study First Received:	March 1, 2007
Last Updated:	February 9, 2009
ClinicalTrials.gov Identifier:	NCT00442546 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

opioid

Additional relevant MeSH terms:

Osteoarthritis
Joint Diseases
Physiological Effects of Drugs
Pregabalin
Pain
Rheumatic Diseases
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Musculoskeletal Diseases

Postoperative Complications
Sensory System Agents
Therapeutic Uses
Arthritis
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Anticonvulsants
Pain, Postoperative

ClinicalTrials.gov processed this record on November 27, 2009