Study of PF614 Pain Relief After Abdominoplasty Surgery Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Safety and Effectiveness of Oral PF614

What this Trial Is About

Researchers are evaluating the pain-relieving effects of PF614, an oral extended-release oxycodone prodrug, for controlling moderate to severe pain after abdominoplasty surgery. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to compare the effectiveness and safety of different doses of PF614 against placebo. The study includes several phases screening, treatment, outpatient, and follow-up to thoroughly assess the medications impact and tolerability. During the treatment phase, participants are admitted on the day of surgery and remain in the clinic for 5 days. They are randomly assigned to one of four groups receiving PF614 at doses of 25 mg, 37.5 mg, 50 mg, or placebo, given orally every 12 hours starting approximately one hour before surgery. The surgery involves a full abdominoplasty without liposuction, and participants receive a standardized anesthetic protocol including a transversalis abdominal plane block. Rescue pain medication is allowed under specific conditions. After the inpatient period, participants continue to record pain and any side effects at home for several days. Participants will rate their pain using a numerical scale at rest and with movement at scheduled times up to 5 days after surgery. Blood samples are collected to monitor drug levels, and sedation is assessed by trained staff. Safety is closely monitored during the inpatient stay, with follow-up visits scheduled about a week after surgery. The main outcome measured is the area under the curve of pain ratings over 48 hours, along with several secondary measures including rescue medication use, treatment satisfaction, and safety outcomes.

PF614 Analgesic Activity in Acute Postoperative Pain (PF614-301)