The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine administered as needed (PRN) compared with placebo in patients with moderate to severe acute postoperative pain after bunionectomy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
418
Research Site
Phoenix, Arizona, United States
Research Site
Anaheim, California, United States
Research Site
Pasadena, California, United States
Research Site
Pasadena, Maryland, United States
Number of Patients Who Respond to Study Medication at the 48-hr Numeric Pain Rating Scale (NRS) Assessment Compared to Placebo.
Time frame: 48 hours
Number of Respiratory Safety Events Compared to Morphine.
Time frame: 48 hours
Duration of Respiratory Safety Events Compared to Morphine.
Time frame: 48 hours
Odds Ratio of Patients Who Respond to Study Medication at the 48-hr NRS Assessment Compared to Morphine.
Odds ratio of 48-hour responder analysis versus morphine. Number of patients who responded to study medication at the 48-hr NRS assessment is captured in the primary outcome measure.
Time frame: 48 hours
Number of Patients With Treatment-related Adverse Events.
Time frame: 48 hours
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Research Site
Austin, Texas, United States
Research Site
San Antonio, Texas, United States
Resarch Site
Salt Lake City, Utah, United States