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

Pharmbio Korea

Status and phase: Completed; Phase 3

Conditions: Acute Pain

Treatments: Drug: PBK_L1704 0.35mg; Drug: Placebo; Drug: PBK_L1704 0.5mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05509868

PBK_L1704_301

Details and patient eligibility

About

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.

Enrollment: 182 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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182 participants in 3 patient groups, including a placebo group

PBK_L1704 0.35mg

Experimental group

Treatment:

Drug: PBK_L1704 0.35mg

PBK_L1704 0.5mg

Experimental group

Treatment:

Drug: PBK_L1704 0.5mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo