Evaluation of the Safety and Efficacy of a Single Dose of SKY0402 in Subjects Undergoing Augmentation Mammoplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01206608
First received: September 19, 2010
Last updated: July 3, 2013
Last verified: July 2013
  Purpose

The primary objective of this study was to demonstrate the superiority of SKY0402 over conventional, commercially-available bupivacaine HCl with respect to the duration of the analgesic effect achieved by a single local administration of the study drug.


Condition Intervention Phase
Postoperative Pain
Drug: SKY0402 + bupivacaine HCl
Drug: Mid-dose SKY0402 + bupivacaine HCl
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Active-Control Study to Evaluate the Safety and Efficacy of a Single Local Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Augmentation Mammoplasty

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) at Rest (NRS-R) and With Activity (NRS-A) Pain Intensity Scores [ Time Frame: Through 96 hours postdose ] [ Designated as safety issue: No ]
    Assessments of postoperative pain were conducted through 96 hours and included pain intensity at rest (NRS-R) and with activity (NRS-A). The prescribed activity was to consist of raising the arm, in full extension at the elbow and wrist, to a position parallel with the axis of the torso. Pain intensity was scored on an 11-point scale, where 0 = no pain and 10 = worst possible pain.


Secondary Outcome Measures:
  • Number of Participants With Adverse Events [ Time Frame: Through 30 days postdose ] [ Designated as safety issue: Yes ]
    Adverse events were monitored through Day 8 and serious adverse events through Day 30.


Enrollment: 40
Study Start Date: March 2008
Study Completion Date: December 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low-dose SKY0402 + bupivacaine HCl
Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
Drug: SKY0402 + bupivacaine HCl
Low-dose SKY0402 administered locally into one breast pocket and 75 mg bupivacaine HCl administered locally into the other breast pocket
Active Comparator: Mid-dose SKY0402 + bupivacaine HCl
Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
Drug: Mid-dose SKY0402 + bupivacaine HCl
Mid-dose SKY0402 administered locally into one breast pocket and 75 mg bupivacaine HCl administered locally into the other breast pocket

Detailed Description:

This was a Phase 2, parallel-group, active-control, randomized, double-blind study conducted to evaluate a single local administration of low dose or high dose of SKY0402 compared with 75 mg of bupivacaine HCl (i.e., Marcaine® 0.5%) in women undergoing bilateral, cosmetic, sub-muscular, augmentation mammoplasty under general anesthesia. Each subject was to serve as her own control.

A total of 40 subjects were randomized in a 1:1 ratio to receive one of the following regimens:

  • Low-dose SKY0402 in one side and Marcaine 75 mg in the contralateral side.
  • Mid-dose SKY0402 in one side and Marcaine 75 mg in the contralateral side.

Study drug was administered locally into the breast implant pocket at the end of surgery. After surgery, subjects were to receive standard treatment with acetaminophen 1000 mg three times daily and rescue analgesia with immediate-release oxycodone, as needed, for breakthrough pain.

Assessments of postoperative pain were conducted through 96 hours. Safety assessments were conducted including monitoring of local and systemic adverse events (AEs).

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects who met all of the following criteria were eligible for inclusion in the study:

  1. Women, 18-40 years of age at the Screening Visit.
  2. Postmenopausal, surgically sterile, or willing to use an 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.
  3. Scheduled to undergo primary, bilateral, sub-muscular, augmentation mammoplasty under general anesthesia.
  4. American Society of Anesthesiology (ASA) Physical Class 1-3.
  5. Able and willing to comply with all study visits and procedures.
  6. Able to speak, read, and understand the language of the 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:

  • Subjects were not eligible for the study if they met any of the following criteria:

    1. Pregnancy, nursing, or planning to become pregnant during the study or within one month after study drug administration.
    2. Body weight less than 50 kilograms.
    3. History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics or to opioid medication.
    4. Administration of an investigational product within 30 days or 5 elimination half-lives of such investigational product, whichever was longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.
    5. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
    6. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, may interfere with study assessments or compliance.
    7. Significant medical conditions or laboratory results that, in the opinion of the Investigator, indicated an increased vulnerability to study drugs and procedures, and exposed the subject to an unreasonable risk as a result of participating in this clinical trial (e.g., severe hepatic insufficiency, hypotension, heart block, or severely impaired cardiac function).

      In addition, the subject was ineligible to receive study drug if she met the following criterion during surgery:

    8. 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: NCT01206608

Locations
United States, California
Associates for Plastic Surgery
La Jolla, California, United States, 92037
Sponsors and Collaborators
Pacira Pharmaceuticals, Inc
Investigators
Study Director: Kay Warnott, RN, ACNP Pacira Pharmaceuticals, Inc
  More Information

No publications provided

Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01206608     History of Changes
Other Study ID Numbers: SKY0402-C-210
Study First Received: September 19, 2010
Results First Received: November 23, 2011
Last Updated: July 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pacira Pharmaceuticals, Inc:
Breast augmentation
Pain
Analgesia

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
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 July 22, 2014