Acute PainPhase 3NCT05509868
Study of PBK_L1704 for the Treatment of Moderate to Severe Acute Pain After Bunionectomy in South Korea
A Phase 3 study testing PBK_L1704 0.35mg and PBK_L1704 0.5mg in people with Acute Pain, run by Pharmbio Korea Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Acute Pain
- What is being tested?
- PBK_L1704 0.35mg and PBK_L1704 0.5mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Jul 2022to 28 Feb 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- PBK_L1704 0.35mg, PBK_L1704 0.5mg, Placebo
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBK_L1704 0.35mgDrug
The subject will receive PBK_L1704 0.35mg/ml by PCA
PBK_L1704 0.5mgDrug
The subject will receive PBK_L1704 0.5mg/ml by PCA
PlaceboDrug
The subject will receive placebo by PCA
| Study group | Role | What they receive |
|---|---|---|
| PBK_L1704 0.35mg | Experimental | Not described Receives: Drug: PBK_L1704 0.35mg |
| PBK_L1704 0.5mg | Experimental | Not described Receives: Drug: PBK_L1704 0.5mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 48 hours
Secondary outcomes (4)
Responder rate
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.
Measured: 48 hours
Time to rescue pain medication use
Measured: 48 hours
Proportion of rescue pain medication use
Measured: 48 hours
Total rescue pain medication use
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start25 Jul 2022
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmbio Korea Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lee, Principal investigator, Seoul Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509868
- Sponsor's protocol ID
- PBK_L1704_301
- Status last verified
- Jan 2026
- First submitted
- 19 Aug 2022
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41772803
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05509868
- Acronym / sponsor ID
- PBK_L1704_301
- Conditions
- Acute Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Pharmbio Korea Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PBK_L1704 0.35mgThe subject will receive PBK_L1704 0.35mg/ml by PCA | Drug | PBK_L1704 0.35mg |
| PBK_L1704 0.5mgThe subject will receive PBK_L1704 0.5mg/ml by PCA | Drug | PBK_L1704 0.5mg |
| PlaceboThe subject will receive placebo by PCA | Drug | Placebo |
Primary outcome
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).
4 secondary outcomes
Responder rate
Time frame: 48 hours
Time to rescue pain medication use
Time frame: 48 hours
Proportion of rescue pain medication use
Time frame: 48 hours
Total rescue pain medication use
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Derived from this study: PubMed 41772803Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee principal investigator
Seoul Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PBK_L1704 0.35mg and PBK_L1704 0.5mg in people with Acute Pain, run by Pharmbio Korea Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SPID-48 (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05509868, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.