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

NCT01206608 | Completed Phase 2 Results

• 1 other identifier: SKY0402-C-210
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain

Keywords

Breast augmentation; Pain; Analgesia

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) at Rest (NRS-R) and With Activity (NRS-A) Pain Intensity Scores

  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.

  Through 96 hours postdose

Secondary Outcomes (1)

• Number of Participants With Adverse Events

  Through 30 days postdose

Study Arms (2)

Low-dose SKY0402 + bupivacaine HCl

ACTIVE COMPARATOR

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

Mid-dose SKY0402 + bupivacaine HCl

ACTIVE COMPARATOR

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

Interventions

SKY0402 + bupivacaine HCl DRUG

Low-dose SKY0402 administered locally into one breast pocket and 75 mg bupivacaine HCl administered locally into the other breast pocket

Low-dose SKY0402 + bupivacaine HCl

Mid-dose SKY0402 + bupivacaine HCl DRUG

Mid-dose SKY0402 administered locally into one breast pocket and 75 mg bupivacaine HCl administered locally into the other breast pocket

Mid-dose SKY0402 + bupivacaine HCl

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women, 18-40 years of age at the Screening Visit.
• 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.
• Scheduled to undergo primary, bilateral, sub-muscular, augmentation mammoplasty under general anesthesia.
• American Society of Anesthesiology (ASA) Physical Class 1-3.
• Able and willing to comply with all study visits and procedures.
• 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.
• Willing and capable of providing written informed consent.

You may not qualify if:

• Subjects were not eligible for the study if they met any of the following criteria:
• Pregnancy, nursing, or planning to become pregnant during the study or within one month after study drug administration.
• Body weight less than 50 kilograms.
• History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics or to opioid medication.
• 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.
• 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.
• 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:
• 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.

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (1)

Associates for Plastic Surgery

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain; Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Executive Medical Director
• Organization: Pacira Pharmaceuticals, Inc.

ErolOnel@pacira.com

203-837-6500

Study Officials

• Kay Warnott, RN, ACNP

  Pacira Pharmaceuticals, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2010
• First Posted: September 22, 2010
• Study Start: March 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 2, 2021
• Results First Posted: August 6, 2013

Record last verified: 2021-02

Locations

US (1)