CBP-0276 to Reduce Opioid Use in Adults Undergoing Major Orthopedic Surgery

Randomized, Phase 2, Proof‐of‐concept, double‐blind, parallel‐group, placebo controlledclinical study to evaluate the safety and efficacy of CBP‐0276 at doses of 600 mg/day inreducing opioid use in pain management in adult patients undergoing major orthopedicsurgery. Subjects will be allocated in 2 groups. One group (n=40) will receive oxycodone(standard of care) + CBP‐0276 at a dose of 600 mg, orally once daily for 28 days. Asecond group (n=40) will receive oxycodone (standard of care) + placebo for CBP‐0276,orally once daily for 28 days. Primary outcome is the reduction on the number ofoxycodone tablets required to controlled the moderate to severe pain management duringthe 28 days post‐major orthopaedic surgery. Secondary and Exploratory outcomes are: A)Number of days where the use of oxycodone is required; B) Changes in quality of lifeaccording to the WHOQOL‐BREF score, from baseline and at 28 days post‐surgery; C) Thenumber of oxycodone tablets required for pain management at day 15 post‐surgical; D)Frequency and intensity of pain at day 28 post‐surgery and at 3 months of post‐surgicalfollow‐up; E) Changes on inflamatory cytokines between baseline and end of treatment (day28) Characteristics of the subject to be enrolled included age between 40 and 75y, maleor female, BMI 18.5 to 35, under surgery of hip or knee replacement.