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

Last updated: January 28, 2026
Sponsor: Pharmbio Korea Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Acute Pain

Pain

Treatment

Placebo

PBK_L1704 0.5mg

PBK_L1704 0.35mg

Clinical Study ID

NCT05509868
PBK_L1704_301
  • Ages 19-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Scheduled to undergo primary, unilateral, first metatarsal bunionectomy withosteotomy and internal fixation

  • Able to understand and comply with the study procedures and requirements, and ableto provide written informed consent before any study procedure.

Exclusion

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 substanceabuse condition or history of such condition that could confound the interpretationof efficacy, safety or tolerability data in the study.

  • American Society of Anesthesiologists (ASA) Physical Status Classification Systemclassification III or worse.

Study Design

Total Participants: 182
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 3
Study Start date:
July 25, 2022
Estimated Completion Date:
February 28, 2025

Connect with a study center

  • Seoul Asan medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Seoul Asan medical Center

    Seoul 1835848,
    South Korea

    Site Not Available

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