NCT05509868

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2022

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2022

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

2.6 years

First QC Date

August 19, 2022

Last Update Submit

January 28, 2026

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

  • SPID-48

    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).

    48 hours

Secondary Outcomes (4)

  • Responder rate

    48 hours

  • Time to rescue pain medication use

    48 hours

  • Proportion of rescue pain medication use

    48 hours

  • Total rescue pain medication use

    48 hours

Study Arms (3)

PBK_L1704 0.35mg

EXPERIMENTAL
Drug: PBK_L1704 0.35mg

PBK_L1704 0.5mg

EXPERIMENTAL
Drug: PBK_L1704 0.5mg

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PBK_L1704 0.35mgDRUG

The subject will receive PBK\_L1704 0.35mg/ml by PCA

PBK_L1704 0.35mg
PBK_L1704 0.5mgDRUG

The subject will receive PBK\_L1704 0.5mg/ml by PCA

PBK_L1704 0.5mg
PlaceboDRUG

The subject will receive placebo by PCA

Placebo

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul Asan medical Center

Seoul, South Korea

Location

Related Publications (1)

  • Kim S, Cho BK, Young KW, Sung KS, Lee Y, Ahn JY, Kim BS, Kang C, Lee KB, Park CH, Lee DY, Choi Y, Lee HS. A randomized double-blind placebo-controlled trial of oliceridine, a G protein-biased ligand at the micro-opioid receptor, for management of moderate-to-severe acute pain following bunionectomy. Curr Med Res Opin. 2026 Jan;42(1):151-162. doi: 10.1080/03007995.2026.2632422. Epub 2026 Mar 2.

    PMID: 41772803DERIVED

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lee

    Seoul Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2022

First Posted

August 22, 2022

Study Start

July 25, 2022

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

January 30, 2026

Record last verified: 2026-01

Locations

KR(1)