Bunion, Hallux Valgus
Conditions
Keywords
Bunion, Bunionectomy, Osteotomy
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
Interventions
DRUGSKY0402
Local infiltration of 8cc SKY0402
DRUGPlacebo
Local infiltration of 8cc Placebo
Sponsors
Pacira Pharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event Profile | 30 days | Participants with an Adverse Event through 72 hours or a Serious Adverse Event through 30 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sky0402 Injection of Study Drug | 97 |
| Placebo Study Drug Injection | 96 |
| Total | 193 |
Baseline characteristics
| Characteristic | Placebo | Sky0402 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 0 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 92 Participants | 97 Participants | 189 Participants |
| Age Continuous | 43.2 years STANDARD_DEVIATION 13.3 | 42.4 years STANDARD_DEVIATION 12.6 | 42.8 years STANDARD_DEVIATION 13 |
| Region of Enrollment United States | 96 participants | 97 participants | 193 participants |
| Sex: Female, Male Female | 84 Participants | 75 Participants | 159 Participants |
| Sex: Female, Male Male | 12 Participants | 22 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 56 / 97 | 63 / 96 |
| serious Total, serious adverse events | 0 / 97 | 1 / 96 |
Outcome results
Primary
Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores
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?
Time frame: 0-24 hours
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| SKY0402 | Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores | 124 Units on a scale*hours | Standard Error 4.5 |
| Placebo | Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores | 146 Units on a scale*hours | Standard Error 4.6 |
Secondary
Adverse Event Profile
Participants with an Adverse Event through 72 hours or a Serious Adverse Event through 30 days
Time frame: 30 days