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

Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00813111
• Other study ID #: SIMPLE Breast Augmentation 315
• Status: Terminated
• Phase: Phase 3
• First received: December 9, 2008
• Last updated: November 30, 2013
• Start date: November 2008
• Est. completion date: February 2009

Study information

• Verified date: November 2013
• Source: Pacira Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 136
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• SKY0402
600mg SKY0402 instilled into breast pocket during surgery
• Bupivacaine HCl
200mg Bupivacaine HCl instilled into breast pocket during surgery

Locations

Country	Name	City	State
United States	Research Concepts, Ltd	Bellaire	Texas
United States	West Alabama Research, LLC	Birmingham	Alabama
United States	West Alabama Research, LLC.	Birmingham	Alabama
United States	Back Bay Plastic Surgery	Boston	Massachusetts
United States	The Ohio State University Research Foundation	Columbus	Ohio
United States	Associates for Plastic Surgery Medical Group, Inc.	La Jolla	California
United States	La Jolla Spa MD	La Jolla	California
United States	Waldman and Schantz Plastic Surgery	Lexington	Kentucky
United States	Miami Plastic Surgery	Miami	Florida
United States	Horizon Research Group, Inc	Mobile	Alabama
United States	Lotus Clinical Research	Pasadena	California
United States	North Fulton Plastic Surgery	Roswell	Georgia
United States	Pacific Plastic Surgery	Santa Barbara	California
United States	Personal Enhancement Center	Toms River	New Jersey
United States	Office of Dr. William P. Adams, Jr., MD	University Park	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores	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	Yes
Secondary	Number of Participants With Adverse Events		30 days	Yes