(237) Novel design to evaluate the efficacy and safety of an abuse-deterrent, extended-release oxycodone product candidate in patients with moderate-to-severe chronic low back pain

Chronic pain trials often use randomized withdrawal study designs with relatively short (4-week) open-label titration periods and relatively long (3-month) randomized withdrawal phases. Conversion to study medication during short open-label periods may result in patients being locked into ineffective doses resulting in higher discontinuation rates in the active treatment group during the double-blind withdrawal period. The long randomized...