Bunion - Clinical trial details 

Recruitment status:

Not recruiting

Primary Sponsor:

Pacira Pharmaceuticals, Inc

Recruitment countries:

United States

Health condition studied:

Bunion

URL:

Link to the clinical trial website

About the trial

Interventions:

Drug: NaCl
Drug: SKY0402

Key inclusion and exclusion 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 NSAID including selective COX-2 inhibitor within three days of surgery - Use of acetaminophen within 24 hours of surgery - Use of 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

• Age minimum: 18 Years
• Age maximum: N/A
• Gender: Both

Primary outcomes:

The primary outcome measure is the area under the curve (AUC0-24) of the numeric rating scale (NRS) pain intensity scores through 24 hours for subjects receiving SKY0402 vs. placebo

Secondary outcomes:

Target sample size:

186

Study type:

Interventional

Study design:

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Contacts:

• Name: Stephen Daniels, DO
• Address:
• Phone:
• Email:
• Affiliation: Premier Research Group Clinical Research Center

Technical details

Scientific 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)

Sources of monetary support:

Please refer to primary and secondary sponsors

Secondary sponsors:

Main ID:

NCT00890682

Secondary ID:

SKY0402C317

Register:

ClinicalTrials.gov

Date of registration:

28/04/2024

Date of first enrollment:

April 2009

Last refreshed:

3 June 2024