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

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of PBK_L1704 for the Treatment of Moderate to Severe Acute Pain After Bunionectomy in South Korea

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Pain
• Intervention / Treatment: Drug: PBK_L1704 0.35mg; Drug: PBK_L1704 0.5mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 225
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Manager Clinical Trial team, Pharmbio Korea; Phone Number: +82-2-587-2551; Email: cr@pharmbio.co.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul ASAN Medical Center
    • Principal Investigator: Lee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; The subject will receive placebo by PCA
Experimental: PBK_L1704 0.35mg	Drug: PBK_L1704 0.35mg; The subject will receive PBK_L1704 0.35mg/ml by PCA
Experimental: PBK_L1704 0.5mg	Drug: PBK_L1704 0.5mg; The subject will receive PBK_L1704 0.5mg/ml by PCA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SPID-48	Sum of Pain Intensity Differences (SPID) from baseline to 48 hours	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder rate	A patient is a responder if their final time-weighted Sum of Pain Intensity Differences from baseline (SPID-48) corresponds to, or is greater than, a 30% improvement.	48 hours
Time to rescue pain medication use		48 hours
Proportion of rescue pain medication use		48 hours
Total rescue pain medication use		48 hours

Collaborators and Investigators

• Sponsor: Pharmbio Korea Co., Ltd.
• Investigators: Principal Investigator: Lee, Seoul ASAN Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2022
• Primary Completion (Anticipated): December 26, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: August 19, 2022
• First Submitted That Met QC Criteria: August 19, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Actual): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: PBK_L1704_301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No