Study of PBK_L1704 for the Treatment of Moderate to Severe Acute Pain After Bunionectomy in South Korea
NCT05509868 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 182
Last updated 2026-01-30
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
- 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
-
The subject will receive placebo by PCA
Sponsors & Collaborators
-
Pharmbio Korea Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Lee · Seoul Asan Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-25
- Primary Completion
- 2025-02-28
- Completion
- 2025-02-28
Countries
- South Korea
Study Locations
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