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

Tracking Information

First Received Date ^ICMJE

March 1, 2007

Last Updated Date

February 9, 2009

Start Date ^ICMJE

May 2007

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

To assess the efficacy of pregabalin compared to placebo on pain following total knee arthroplasty using a subject reported assessment of worst pain.

Change History

Complete list of historical versions of study NCT00442546 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Effect of pregabalin on rescue medication/opioid sparing
Effect of pregabalin on the occurrence of opioid related symptoms
Evaluate the effect of pregagbalin on pain interference with functional activities
Evaluate safety and tolerability of pregabalin
Evaluate the effect of pregabalin at reducing post-operative pain at different time points post total knee arthroplasty
To evaluate the effect of pregabalin on time to eligibility for hospital discharge and time to actual hopsital discharge
To evaluate the effect of pregabalin on pain-related sleep interference
To evaluate the effect of pregabalin on treatment satisfaction with study medication
To evaluate the effect of pregabalin on pre-operative anxiety
To evaluate the effect of pregabalin on persistent post-operative pain
To evaluate the presence of neuropathic pain symptoms at 3 and 6 months post surgery

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Osteoarthritis
Postoperative Pain

Intervention ^ICMJE

Drug: pregabalin
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

307

Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00442546

Responsible Party

Clinical Trials Disclosure Group, Pfizer, Inc

Study ID Numbers ^ICMJE

A0081133

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

February 2009

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