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Completed

NCT Number: NCT05509868

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.

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul Asan medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PBK_L1704 0.35mg

Drug

The subject will receive PBK_L1704 0.35mg/ml by PCA

PBK_L1704 0.5mg

Drug

The subject will receive PBK_L1704 0.5mg/ml by PCA

Placebo

Drug

The subject will receive placebo by PCA

Primary outcomes

  1. SPID-48

    Time frame: 48 hours

    Sum of Pain Intensity Difference over 48 hours (SPID-48), calculated from pain intensity scores measured using the Numeric Rating Scale (NRS; 0-10 points), where 0 indicates no pain and 10 indicates the worst possible pain. SPID-48 represents the time-weighted sum of pain intensity differences from baseline across the 48-hour assessment period. Higher SPID-48 values indicate greater pain relief (better outcome).

Secondary outcomes

  1. Responder rate

    Time frame: 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.

  2. Time to rescue pain medication use

    Time frame: 48 hours

  3. Proportion of rescue pain medication use

    Time frame: 48 hours

  4. Total rescue pain medication use

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

Pharmbio Korea Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2022
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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