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

Acute Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05509868
• Other study ID #: PBK_L1704_301
• Status: Recruiting
• Phase: Phase 3
• Start date: July 20, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: July 2022
• Source: Pharmbio Korea Co., Ltd.
• Contact: Manager Clinical Trial team, Pharmbio Korea
• Phone: +82-2-587-2551
• Email: cr[@]pharmbio.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: December 30, 2022
• Est. primary completion date: December 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• PBK_L1704 0.35mg
The subject will receive PBK_L1704 0.35mg/ml by PCA
• PBK_L1704 0.5mg
The subject will receive PBK_L1704 0.5mg/ml by PCA
• Placebo
The subject will receive placebo by PCA

Locations

Country	Name	City	State
Korea, Republic of	Seoul Asan medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Pharmbio Korea Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SPID-48	Sum of Pain Intensity Differences (SPID) from baseline to 48 hours	48 hours
Secondary	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
Secondary	Time to rescue pain medication use		48 hours
Secondary	Proportion of rescue pain medication use		48 hours
Secondary	Total rescue pain medication use		48 hours