Efficacy And Safety Of Pregabalin For Pain Following Total Knee Replacement

NCT00442546 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: A0081133
• Study Type: interventional
• Target: 307
• Locations: 1 country
• Sites: 27

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.

Conditions

Osteoarthritis; Postoperative Pain

Keywords

opioid

Outcome Measures

Primary Outcomes (1)

• Subject Reported Worst Pain Score in Daily Diaries Using the Worst Pain Item of the Modified Brief Pain Inventory - Short Form (m-BPI-sf)

  The mBPI-SF is a self administered questionnaire developed to assess pain severity and pain interference with functional activities during a 24-hour period prior to evaluation. For the Worst Pain item of the m-BPI-sf scale (11 point Likert scale; range: 0 \[no pain\] to 10 \[pain as bad as you can imagine\]), subjects were asked to rate their pain by marking an "X" in one of the ten boxes that best described their pain at its worst in the last 24 hours post surgery and at least 12 hours after discontinuation of the peripheral nerve block or neuroaxial block.

  48 hours after surgery

Secondary Outcomes (41)

• Cumulative Total Amount of Opioids Used During the Entire Hospital Stay

  24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, 192 hours, 216 hours

• Opioids Used Post Discharge

  Week 2, Week 4, Week 6/Early Termination (ET)

• Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol)

  24 hours, 48 hours, 72 hours

• Analgesics Used Post Discharge (Acetylsalicylic Acid [Week 2] and Paracetamol [Weeks 2, 4, and 6]

  Week 2, Week 4, Week 6/ET

• Analgesics Used Post Discharge (Ibuprofen) for the Pregabalin 150 mg and Placebo Treatment Groups

  Week 2, Week 4, Week 6/ET

Study Arms (3)

1

EXPERIMENTAL

Drug: pregabalin

2

EXPERIMENTAL

Drug: pregabalin

3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

pregabalin DRUG

150 milligram (mg)/ day (double blind)

1

Placebo DRUG

Placebo

3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (27)

Pfizer Investigational Site

Northport, Alabama, 35476, United States

Location

Pfizer Investigational Site

Tuscaloosa, Alabama, 35401, United States

Location

Pfizer Investigational Site

Tuscaloosa, Alabama, 35406, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85023, United States

Location

Pfizer Investigational Site

Little Rock, Arkansas, 72205, United States

Location

Pfizer Investigational Site

Miami, Florida, 331036, United States

Location

Pfizer Investigational Site

Vero Beach, Florida, 32960, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60612, United States

Location

Pfizer Investigational Site

Galesburg, Illinois, 61401, United States

Location

Pfizer Investigational Site

Lafayette, Louisiana, 70503, United States

Location

Pfizer Investigational Site

New Iberia, Louisiana, 70563, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21218, United States

Location

Pfizer Investigational Site

Egg Harbor, New Jersey, 08234, United States

Location

Pfizer Investigational Site

Pomona, New Jersey, 08205, United States

Location

Pfizer Investigational Site

Voorhees Township, New Jersey, 08043, United States

Location

Pfizer Investigational Site

New York, New York, 10021, United States

Location

Pfizer Investigational Site

Charlotte, North Carolina, 28207, United States

Location

Pfizer Investigational Site

Columbus, Ohio, 43214, United States

Location

Pfizer Investigational Site

Columbus, Ohio, 43215, United States

Location

Pfizer Investigational Site

Upper Arlington, Ohio, 43220, United States

Location

Pfizer Investigational Site

Allentown, Pennsylvania, 18103, United States

Location

Pfizer Investigational Site

King of Prussia, Pennsylvania, 19406, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19107, United States

Location

Pfizer Investigational Site

Pittsburgh, Pennsylvania, 15213-2582, United States

Location

Pfizer Investigational Site

Pittsburgh, Pennsylvania, 15232, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75390, United States

Location

Pfizer Investigational Site

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 25565885 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Pain, Postoperative

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2007
• First Posted: March 2, 2007
• Study Start: May 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 22, 2021
• Results First Posted: August 18, 2010

Record last verified: 2018-10

Locations

US (27)