Phase 3 Study of Local Administration of SKY0402 for Postoperative Analgesia in Subject Undergoing Breast Augmentation

This study has been terminated.
(Sponsor decision, unrelated to safety)
Sponsor:
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00813111
First received: December 9, 2008
Last updated: November 30, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to provide a more effective postoperative method of pain control for patients undergoing cosmetic sub-muscular breast augmentation. Appropriate postoperative pain management contributes to faster patient mobilization, shortened hospital stays, and reduced healthcare costs.


Condition Intervention Phase
Pain
Drug: SKY0402
Drug: Bupivacaine HCl
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: A Phase 3, Multicenter, Randomized, Double-blind Parallel-group, Active-control Study to Evaluate the Safety and Efficacy of Local Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Bilateral, Cosmetic Sub-muscular Breast Augmentation

Resource links provided by NLM:


Further study details as provided by Pacira Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores [ Time Frame: through 72 hours ] [ Designated as safety issue: Yes ]

    Assessments of postoperative pain included pain intensity at rest (using the NRS at rest [NRS-R] and with activity [using the NRS-A]) where the prescribed activity was raising both arms.

    Pain intensity was assessed on a scale of 0 to 10, where 0=no pain and 10=worst possible pain.



Secondary Outcome Measures:
  • Number of Participants With Adverse Events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 136
Study Start Date: November 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SKY0402
A single local administration of 300 mg in a 20-mL volume into each breast implant pocket for a total dose of 600 mg (i.e., a total of 40 mL)
Drug: SKY0402
600mg SKY0402 instilled into breast pocket during surgery
Other Name: EXPAREL
Active Comparator: Bupivacaine HCl
A single local administration of 100 mg in a 20-mL volume into each breast implant pocket for a total dose of 200 mg (i.e., a total of 40 mL)
Drug: Bupivacaine HCl
200mg Bupivacaine HCl instilled into breast pocket during surgery
Other Name: Marcaine 0.5% with epinephrine

Detailed Description:

This is a phase 3 study conducted to evaluate the safety and efficacy of a single local administration of 300 mg of SKY0402 compared with 100 mg of conventional, commercially-available bupivacaine HCl (i.e. Marcaine 0.5% with epinephrine) administered locally into the implant pocket of each breast for postoperative analgesia in subjects undergoing bilateral, cosmetic, sub-muscular, breast augmentation under general anesthesia (endotracheal or otherwise). A total of 600 mg of SKY0402 or 200 mg bupivacaine HCl per subject is therefore administered. Post-operative assessments were conducted including adverse event and serious adverse event monitoring through Day 30.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Women greater than or equal to 18 years of age at Screening Visit
  2. 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 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.
  3. Scheduled to undergo primary, bilateral, cosmetic, sub-muscular, breast augmentation under general anesthesia (endotracheal or otherwise)
  4. American Society of Anesthesiologist (ASA) Physical Class 1-4
  5. Able and willing to comply with all study visits and procedures, and with diary entries through postoperative day 8
  6. Able to speak, read, and understand the language of the informed consent form (ICF), 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
  7. Willing and capable of providing written informed consent.

Exclusion Criteria:

A subject will not be eligible for the study if she meets any of the following criteria:

  1. Women undergoing reconstructive surgery following mastectomy
  2. Pregnancy, nursing, or planning to become pregnant during the study or within one month after study drug administration.
  3. Use of any of the following medications within the times specified before surgery:

    1. long-acting opioids within 3 days.
    2. Any opioid medication within 24 hours.
  4. 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 abdominal surgery, etc.), which have the potential to confound the postoperative study assessments.
  5. Body weight less than 50 kilograms (110 pounds)
  6. History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics, opioid medication, epinephrine, or sulfites.
  7. Contraindication to epinephrine, such as concurrent administration of ergot-type drugs, monoamine oxidase (MAO) inhibitors or antidepressants of tryptoline or imipramine types, conditions where the production or exacerbation of tachycardia could provide fatal (e.g., poorly controlled thyrotoxicosis or severe heart disease) or any other pathological conditions that might be aggravated by the effect of epinephrine.
  8. Administration of investigational product within 30 days of 5 elimination half-lives of such investigational product, 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.
  9. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
  10. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance with the protocol.
  11. 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, co-morbid 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 she meets the following criteria during surgery:

  12. Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postoperative course.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813111

Locations
United States, Alabama
West Alabama Research, LLC.
Birmingham, Alabama, United States, 35209
West Alabama Research, LLC
Birmingham, Alabama, United States, 35209
Horizon Research Group, Inc
Mobile, Alabama, United States, 36608
United States, California
La Jolla Spa MD
La Jolla, California, United States, 90237
Associates for Plastic Surgery Medical Group, Inc.
La Jolla, California, United States, 92037
Lotus Clinical Research
Pasadena, California, United States, 91105
Pacific Plastic Surgery
Santa Barbara, California, United States, 93105
United States, Florida
Miami Plastic Surgery
Miami, Florida, United States, 33176
United States, Georgia
North Fulton Plastic Surgery
Roswell, Georgia, United States, 30076
United States, Kentucky
Waldman and Schantz Plastic Surgery
Lexington, Kentucky, United States, 40508
United States, Massachusetts
Back Bay Plastic Surgery
Boston, Massachusetts, United States, 02116
United States, New Jersey
Personal Enhancement Center
Toms River, New Jersey, United States, 08753
United States, Ohio
The Ohio State University Research Foundation
Columbus, Ohio, United States, 43210
United States, Texas
Research Concepts, Ltd
Bellaire, Texas, United States, 77402
Office of Dr. William P. Adams, Jr., MD
University Park, Texas, United States, 75205
Sponsors and Collaborators
Pacira Pharmaceuticals, Inc
Investigators
Study Director: Kay Warnott, RN Pacira Pharmaceuticals, Inc
  More Information

No publications provided

Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00813111     History of Changes
Other Study ID Numbers: SIMPLE Breast Augmentation 315
Study First Received: December 9, 2008
Results First Received: November 22, 2011
Last Updated: November 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pacira Pharmaceuticals, Inc:
Postsurgical pain
Analgesia
Breast augmentation

Additional relevant MeSH terms:
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014