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

Phase 3

• Conditions: Acute Pain
• Interventions: Drug: PBK_L1704 0.5mg; Drug: PBK_L1704 0.35mg; Drug: Placebo

• Registration Number: NCT05509868
• Lead Sponsor: Pharmbio Korea Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-07
• Study Start: 2022-07-20
• Study First Submitted: 2022-08-19
• Study First Submitted QC: 2022-08-19
• Last Update Submitted: 2022-08-19
• Study First Posted: 2022-08-22
• Last Update Posted: 2022-08-22
• Primary Completion: 2022-12-26
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 225

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PBK_L1704 0.5mg	PBK_L1704 0.5mg	-
PBK_L1704 0.35mg	PBK_L1704 0.35mg	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
SPID-48	48 hours	Sum of Pain Intensity Differences (SPID) from baseline to 48 hours

Secondary Outcome Measures

Name	Time	Method
Responder rate	48 hours	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.
Time to rescue pain medication use	48 hours
Proportion of rescue pain medication use	48 hours
Total rescue pain medication use	48 hours

Trial Locations

Locations (1)

Seoul Asan medical Center; 🇰🇷 Seoul, Korea, Republic of