Study of Postoperative Analgesia in Bunionectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00890682
First received: April 28, 2009
Last updated: July 2, 2013
Last verified: July 2013
  Purpose

After undergoing bunion surgery, patients are given a pain medicine injection that may last for up to several days or a placebo. Their pain and pain medicine use is then monitored.


Condition Intervention Phase
Bunion
Hallux Valgus
Drug: SKY0402
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing First Metatarsal Osteotomy (Bunionectomy)

Further study details as provided by Pacira Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores [ Time Frame: 0-24 hours ] [ Designated as safety issue: No ]

    The AUC of the NRS-R pain intensity scores from time 0 through 24 hours

    The subject was to rest for at least 5 minutes before responding to the following question, "On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain are you having right now?"



Secondary Outcome Measures:
  • Adverse Event Profile [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Participants with an Adverse Event through 72 hours or a Serious Adverse Event through 30 days


Enrollment: 193
Study Start Date: April 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sky0402
Injection of Study Drug
Drug: SKY0402
Local infiltration of 8cc SKY0402
Other Name: EXPAREL
Placebo Comparator: Placebo
Injection of study drug
Drug: Placebo
Local infiltration of 8cc Placebo
Other Name: saline 0.9%

Detailed Description:

Following drug study administration, safety and efficacy assessments were conducted

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years at the Screening visit
  • Scheduled to undergo primary unilateral first metatarsal osteotomy without hammertoe
  • Female subjects must be surgically sterile or at least two years menopausal, or using an acceptable method of birth control. If of childbearing potential, have a documented negative blood or urine pregnancy test within 24 hours before surgery
  • Clinical laboratory values less than or equal to twice the upper limit of normal or, if abnormal, deemed not clinically significant per the Investigator
  • Ability to provide informed consent, adhere to the study visit schedule and complete all study assessments

Exclusion Criteria:

  • Currently pregnant, nursing, or planning to become pregnant during the study or within one month after study drug administration
  • Chronic user of analgesic medications, including taking opioid medications for more than 14 days in the last 3 months, or non-opioid pain medications more than 5 times per week
  • Use of any non-steroidal anti-inflammatory drug (NSAID) including selective COX-2 inhibitor within three days of surgery
  • Use of acetaminophen within 24 hours of surgery
  • Use of selective serotonin reuptake inhibitors (SSRIs), gabapentin, pregabalin (Lyrica), duloxetine (Cymbalta) within three days of surgery
  • Current use of systemic glucocorticosteroids or use of systemic glucocorticoids within one month of enrollment into this study
  • Peripheral neuropathy including diabetic neuropathy, chemotherapy-induced neuropathy, HIV neuropathy
  • History of hepatitis
  • History of, suspected, or known addiction to or abuse of drugs or alcohol within the past two years
  • Failure to pass urine drug screen
  • Current evidence of alcohol abuse (greater than 4 units of alcohol per day: 1 unit = ½ pint of beer, 1 glass of wine or 1 oz. of spirits)
  • Evidence of peripheral ischemic disease
  • Type I or Type II diabetes
  • Current acute or chronic medical or major psychiatric disease that, in the opinion of the Investigator, would interfere with the evaluation of study drug efficacy or safety
  • Malignancy in the last 2 years, with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix
  • Administration of an investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
  • Previous participation in a SKY0402 study
  • Significant medical conditions or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to study drugs and procedures
  • Current painful physical conditions or concurrent surgery other than bunionectomy that may require analgesic treatment (such as NSAID or opioid) in the postoperative period for pain that is not strictly related to the bunionectomy procedure and may confound the postoperative assessments
  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: NCT00890682

Locations
United States, Texas
Premier Research Group
Austin, Texas, United States, 78705
Sponsors and Collaborators
Pacira Pharmaceuticals, Inc
Investigators
Principal Investigator: Stephen Daniels, DO Premier Research Group Clinical Research Center
  More Information

No publications provided by Pacira Pharmaceuticals, Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00890682     History of Changes
Other Study ID Numbers: SKY0402C317
Study First Received: April 28, 2009
Results First Received: November 21, 2011
Last Updated: July 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pacira Pharmaceuticals, Inc:
Bunion
Bunionectomy
Osteotomy

Additional relevant MeSH terms:
Hallux Valgus
Foot Deformities
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 18, 2014