Phase 3 Study of Local Administration of SKY0402 for Postoperative Analgesia in Subject Undergoing Breast Augmentation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00813111|
Recruitment Status : Terminated (Sponsor decision, unrelated to safety)
First Posted : December 22, 2008
Results First Posted : January 16, 2014
Last Update Posted : January 16, 2014
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|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: SKY0402 Drug: Bupivacaine HCl||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||136 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, 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|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||February 2009|
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)
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
- Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores [ Time Frame: through 72 hours ]
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.
- Number of Participants With Adverse Events [ Time Frame: 30 days ]
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, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
- Women greater than or equal to 18 years of age at Screening Visit
- 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.
- Scheduled to undergo primary, bilateral, cosmetic, sub-muscular, breast augmentation under general anesthesia (endotracheal or otherwise)
- American Society of Anesthesiologist (ASA) Physical Class 1-4
- Able and willing to comply with all study visits and procedures, and with diary entries through postoperative day 8
- 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
- Willing and capable of providing written informed consent.
A subject will not be eligible for the study if she meets any of the following criteria:
- Women undergoing reconstructive surgery following mastectomy
- Pregnancy, nursing, or planning to become pregnant during the study or within one month after study drug administration.
Use of any of the following medications within the times specified before surgery:
- long-acting opioids 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 abdominal surgery, etc.), which have the potential to confound the postoperative study assessments.
- Body weight less than 50 kilograms (110 pounds)
- History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics, opioid medication, epinephrine, or sulfites.
- 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.
- 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.
- History of, 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 with the protocol.
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:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00813111
|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|
|Study Director:||Kay Warnott, RN||Pacira Pharmaceuticals, Inc|
|Responsible Party:||Pacira Pharmaceuticals, Inc|
|Other Study ID Numbers:||
SIMPLE Breast Augmentation 315
|First Posted:||December 22, 2008 Key Record Dates|
|Results First Posted:||January 16, 2014|
|Last Update Posted:||January 16, 2014|
|Last Verified:||November 2013|
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