- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00813111
Phase 3 Study of Local Administration of SKY0402 for Postoperative Analgesia in Subject Undergoing Breast Augmentation
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 Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35209
- West Alabama Research, LLC.
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Birmingham, Alabama, United States, 35209
- West Alabama Research, Llc
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Mobile, Alabama, United States, 36608
- Horizon Research Group, Inc
-
-
California
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La Jolla, California, United States, 90237
- La Jolla Spa MD
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La Jolla, California, United States, 92037
- Associates for Plastic Surgery Medical Group, Inc.
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Pasadena, California, United States, 91105
- Lotus Clinical Research
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Santa Barbara, California, United States, 93105
- Pacific Plastic Surgery
-
-
Florida
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Miami, Florida, United States, 33176
- Miami Plastic Surgery
-
-
Georgia
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Roswell, Georgia, United States, 30076
- North Fulton Plastic Surgery
-
-
Kentucky
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Lexington, Kentucky, United States, 40508
- Waldman and Schantz Plastic Surgery
-
-
Massachusetts
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Boston, Massachusetts, United States, 02116
- Back Bay Plastic Surgery
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New Jersey
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Toms River, New Jersey, United States, 08753
- Personal Enhancement Center
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Ohio
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Columbus, Ohio, United States, 43210
- The Ohio State University Research Foundation
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Texas
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Bellaire, Texas, United States, 77402
- Research Concepts, Ltd
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University Park, Texas, United States, 75205
- Office of Dr. William P. Adams, Jr., MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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)
|
600mg SKY0402 instilled into breast pocket during surgery
Other Names:
|
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)
|
200mg Bupivacaine HCl instilled into breast pocket during surgery
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
through 72 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants With Adverse Events
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Anesthetics, Local
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Bupivacaine
- Epinephrine
Other Study ID Numbers
- SIMPLE Breast Augmentation 315
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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