NCT05509868

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Pharmbio Korea Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	PBK_L1704 0.35mg	The subject will receive PBK\_L1704 0.35mg/ml by PCA
DRUG	PBK_L1704 0.5mg	The subject will receive PBK\_L1704 0.5mg/ml by PCA
DRUG	Placebo	The subject will receive placebo by PCA

Timeline

• Start date: 2022-07-25
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2022-08-22
• Last updated: 2026-01-30

Locations

1 site across 1 country: South Korea