Study of PBK_L1704 for the Treatment of Moderate to Severe Acute Pain After Bunionectomy in South Korea

• Status: Recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to evaluate the analgesic efficacy of PBK_L1704 compared with placebo in patients with moderate to severe acute pain after bunionectomy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmbio Korea Co., Ltd.

Criteria

Inclusion Criteria:

• Scheduled to undergo primary, unilateral, first metatarsal bunionectomy with osteotomy and internal fixation

• Able to understand and comply with the study procedures and requirements, and able to provide written informed consent before any study procedure.

Exclusion Criteria:

• Participated in another oliceridine clinical study.

• Received any investigational drug, device or therapy within 35 days before surgery.

• Clinically significant medical, surgical, postsurgical, psychiatric or substance abuse condition or history of such condition that could confound the interpretation of efficacy, safety or tolerability data in the study.

• American Society of Anesthesiologists (ASA) Physical Status Classification System classification III or worse.