Study of Postoperative Analgesia in Bunionectomy

Phase 3

Completed

Conditions: Bunion
Hallux Valgus

Interventions: Drug: Placebo
Drug: SKY0402

Registration Number: NCT00890682

Lead Sponsor: Pacira Pharmaceuticals, Inc

Brief Summary: 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.

Detailed Description: Following drug study administration, safety and efficacy assessments were conducted

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 193

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Injection of study drug
Sky0402	SKY0402	Injection of Study Drug

Primary Outcome Measures

Name	Time	Method
Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores	0-24 hours	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