A Phase 3 Study to Evaluate the Safety and Efficacy of SKY0402 in Subjects Undergoing Total Knee Arthroplasty

NCT00745290 | Completed Phase 3 Results

• 1 other identifier: SIMPLE TKA 311
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 19

Brief Summary

The primary objective is to demonstrate that SKY0402 is superior when compared to bupivacaine HCl in the management of postoperative pain for patients undergoing total knee arthroplasty.

Conditions

Postoperative Pain

Keywords

Total knee arthroplasty; Pain; Analgesia

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores

  The subject's pain intensity was assessed with activity (NRS-A), while actively flexing the involved knee from the maximum extension point to the maximum flexion point possible. The subject responded to the following question, "On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain did you have while bending your knee?"

  through 72 hours post surgery

Secondary Outcomes (1)

• Number of Participants With Adverse Events Through 96 Hours and Serious Adverse Events Through 30 Days

  through 30 days

Study Arms (2)

Bupivacaine HCl

ACTIVE COMPARATOR

Single dose of 200 mg bupivacaine HCl administered intraoperatively via local infiltration

Drug: Bupivacaine HCl

SKY0402

OTHER

Single dose of 600 mg SKY0402 (study drug) administered intraoperatively via local infiltration

Drug: SKY0402

Interventions

Bupivacaine HCl DRUG

200 mg bupivacaine HCl

Also known as: Marcaine

Bupivacaine HCl

SKY0402 DRUG

600 mg SKY0402 (study drug).

Also known as: DepoBupivacaine

SKY0402

Eligibility Criteria

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

You may qualify if:

• Male or female, ≥18 years of age at the Screening Visit.
• Female subjects only: Postmenopausal, surgically sterile, or willing to use acceptable means of contraception for at least 30 days after surgery including any of the following: hormonal contraceptives (e.g., oral, injectable, implantable starting at least 30 days before study drug administration), effective double-barrier methods (e.g., condoms with spermicide), intrauterine device, lifestyle with a personal choice of abstinence, nonheterosexual lifestyle, or a strictly monogamous relationship with a partner who has had a vasectomy.
• Scheduled to undergo primary unilateral TKA under general or spinal anesthesia.
• American Society of Anesthesiology (ASA) Physical Classification System class 1-4.
• Able and willing to comply with all study visits and procedures.
• Able to speak, read, and understand the language of the informed consent form, study questionnaires, and other instruments used for collecting subject-reported outcomes, in order to enable accurate and appropriate responses to pain scales and other required study assessments.
• Willing and capable of providing written informed consent.

You may not qualify if:

• Pregnancy, nursing, or planning to become pregnant during the study or within one month after dosing.
• Use of any of the following medications within the times specified before surgery:
• Long-acting opioid medication within 3 days.
• Any opioid medication within 24 hours.
• Concurrent painful physical condition or concurrent surgery that may require analgesic treatment in the postoperative period for pain that is not strictly related to the surgical site being administered study drug (e.g., significant pain from other joints, chronic neuropathic pain, concurrent contralateral TKA, concurrent foot surgery, etc.), which have the potential to confound the postoperative study assessments.
• Body weight less than 60 kilograms (\~132 pounds).
• Contraindication to any of the pain-control agents planned for postoperative use (e.g., acetaminophen, morphine, oxycodone, ketorolac).
• Contraindication to epinephrine, such as concurrent administration of ergot-type drugs, monoamine oxidase (MAO) inhibitors or antidepressants of triptoline or imipramine types, conditions where the production or exacerbation of tachycardia could prove fatal (e.g., poorly controlled thyrotoxicosis or severe heart disease), or any other pathological conditions that might be aggravated by the effects of epinephrine.
• Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.
• Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
• Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, may interfere with study assessments or compliance.
• Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may increase the risk of surgery or complicate the subject's postoperative course.
• Significant medical conditions or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to study drugs and procedures, and expose the subject to an unreasonable risk as a result of participating in this clinical trial, such as: debilitating diseases, acute illnesses, hypotension, partial or complete conduction block, impaired cardiac function, untreated hypertension, advanced arteriosclerotic heart disease, cerebral vascular insufficiency, pre-existing abnormal neurological or neuromuscular disease (e.g., epilepsy, myasthenia gravis), advanced liver disease, severe renal impairment, advanced diabetes, comorbid conditions associated with an immunocompromised status, such as blood dyscrasias, HIV/AIDS, or recent chemotherapy.
• In addition, the subject will be ineligible to receive study drug if he or she meets the following criterion during surgery:
• Any clinically significant event or condition uncovered during surgery (e.g., excessive bleeding), which occurs before study drug administration, that might render the subject medically unstable or complicate the subject's postoperative course.

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (19)

West Alabama Research, Inc.

Birmingham, Alabama, 35209, United States

Location

Horizon Research Group, Inc., Alabama Orthopaedic Clinic

Mobile, Alabama, 36608, United States

Location

Drug Research and Analysis Corporation

Montgomery, Alabama, 36106, United States

Location

Sun Health Research Institute, Core Institute

Sun City West, Arizona, 85375, United States

Location

Scripps

La Jolla, California, 92037, United States

Location

Accurate Clinical Trials, Inc.

Laguna Hills, California, 92653, United States

Location

Physicans Clinical Research Corp.

Laguna Hills, California, 92653, United States

Location

Cedars of Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Atlanta Knee and Sports Medicine

Decatur, Georgia, 30033, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Insall Scott Kelly Institute

New York, New York, 10065, United States

Location

CTMG, Inc.

Greenville, North Carolina, 27834, United States

Location

Duke University Medical Center

Raleigh-Durham, North Carolina, 27710, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Allegheny Pain Management

Altoona, Pennsylvania, 16602, United States

Location

Ilumina Clinical Associates

Johnstown, Pennsylvania, 15904, United States

Location

Research Associates of Jackson

Jackson, Tennessee, 38301, United States

Location

Texas Orthopedic Specialists, PA

Grapevine, Texas, 76051, United States

Location

Memorial Hermann City Hospital

Houston, Texas, 77024, United States

Location

Related Publications (1)

• Dasta J, Ramamoorthy S, Patou G, Sinatra R. Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. Curr Med Res Opin. 2012 Oct;28(10):1609-15. doi: 10.1185/03007995.2012.721760. Epub 2012 Sep 3.

  PMID: 22900785 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pain; Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Executive Medical Director
• Organization: Pacira Pharmaceuticals Inc.

ErolOnel@pacira.com

203-837-6500

Study Officials

• Joyce Davis, RN

  Pacira Pharmaceuticals, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: August 29, 2008
• First Posted: September 3, 2008
• Study Start: August 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: February 1, 2009
• Last Updated: August 6, 2013
• Results First Posted: August 6, 2013

Record last verified: 2013-07

Locations

US (19)