post-operative pain management
Conditions
Interventions
Product Name: SKY0402
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: 1-butyl-N-(2,6dimethylphenyl)-2-piperidinecarboxamide
CAS Number: 14252-80-3
Current Sponsor code: SKY0402
Conc
Sponsors
Pacira Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Male or female, = 18 and = 75 years of age at the Screening Visit. •Female subjects only: Postmenopausal, surgically sterile, or willing to use 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 unilateral TKA under general anesthesia. •American Society of Anesthesiology (ASA) Physical Classification System class 1-3 (See Appendix A for details). •Able and willing to comply with all study visits and procedures. •Able to speak, read, and understand the language of the Informed Consent, 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Pregnancy, nursing, or planning to become pregnant during the study or within one month after dosing. •Use of any of the following medications within the times specified before surgery: •Long-acting opioid medication within 3 days. •Any opioid medication within 24 hours. •Concurrent, painful, physical condition or concurrent surgery that may require analgesic treatment in the postoperative period for pain that is not strictly related to the surgical site administered study treatment, and which may confound the postoperative assessments (e.g., significant pain from other joints, chronic neuropathic pain, concurrent contralateral TKA, concurrent foot surgery, etc.). •Body weight less than 50 kilograms (110 pounds) or morbid obesity. •Contraindication to any of the pain-control agents planned for postoperative use (e.g., acetaminophen, morphine, oxycodone, ketorolac). •Contraindication to epinephrine, such as concurrent administration of monoamine oxidase (MAO) inhibitors or antidepressants of amitriptyline or imipramine types, conditions where the production or exacerbation of tachycardia could prove fatal (e.g., poorly controlled thyrotoxicosis or severe heart disease), or any other pathological conditions that might be aggravated by the effects of epinephrine. •Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is 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. •Current or historical evidence of any clinically significant disease or condition, especially cardiovascular or neurological conditions that, in the opinion of the Investigator, may increase the risk of surgery or complicate the subject’s postoperative course. •Significant medical conditions or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to study drugs and procedures, and expose the subject to an unreasonable risk as a result of participating in this clinical trial, such as: debilitating diseases, acute illnesses, hypotension, partial or complete conduction block, impaired cardiac function, untreated hypertension, advanced arteriosclerotic heart disease, cerebral vascular insufficiency, pre-existing abnormal neurological or neuromuscular disease (e.g., epilepsy, myasthenia gravis), advanced liver disease, severe renal impairment, advanced diabetes, comorbid conditions associated with an immunocompromised status, such as blood dyscrasias, HIV/AIDS, or recent chemotherapy. •In addition, the subject will be ineligible to receive study drug if he or she meets the following criterion during surgery: •Any clinically significant event or condition uncovered during surgery (e.g., excessive bleeding), which occurs before study drug administration, that might render the subject medically unstable or complicate the subject’s postoperative course.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): EFFICACY ENDPOINTS The following efficacy endpoints will be assessed based on the efficacy measurements conducted at the specified time points after the start of study drug administration: • Use of supplemental opioid pain medication through Days 2, 3, 4, and 5. • Pain NRS scores at rest (NRS-R) and with activity (NRS A) at each assessed time point. • Time normalized area under the curve (AUCtn) for pain scores using the NRS-R and NRS-A through Days 2, 3, 4, and 5. • An integrated rank assessment using the NRS-R scores and total postoperative opioid usage through Days 2, 3, 4 and 5. • An integrated rank assessment using the NRS-A scores and total postoperative opioid usage through Days 2, 3, 4 and 5. • Individual variables of QOL questionnaire. • Individual variables of pharmacoeconomic questionnaire. • Postoperative nausea and vomiting (PONV)-free time for Days 2, 3, 4, and 5. • Use of antiemetic medication (i.e., any medication given postoperatively to treat nausea and/or vomiting) administered through Days 2, 3, 4, and 5. • An integrated rank assessment using nausea and vomiting free time and use of antiemetic doses through Days 2, 3, 4, and 5. • Time to clinically meaningful physical rehabilitation. • Time to first bowel movement through 96 hours. • Blinded care provider’s satisfaction with postoperative analgesia. • Time to resumption of work or normal daily activities. • Physical therapist’s assessments on Days 1, 2, 3, 4, and 5. SAFETY ENDPOINTS The following safety endpoints will be assessed based on the safety measurements conducted at the specified time points after the start of study drug administration: • Incidence of treatment-emergent AEs (TEAEs) through Day 8 and treatment-emergent SAEs and deaths through Day 36. • Change from Baseline in vital signs (temperature, resting heart rate, and blood pressure) at each assessed time point. • Wound healing and status on Days 2, 3, 4, 5, 8 and 36. • Wound scarring on Day 36. • ECG ab | — |
Countries
Austria, Czech Republic, Denmark, Germany
Outcome results
None listed