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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PBK_L1704 0.35mg | Experimental |
| |
| PBK_L1704 0.5mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PBK_L1704 0.35mg | Drug | The subject will receive PBK_L1704 0.35mg/ml by PCA |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 hours |
| Time to rescue pain medication use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lee | Seoul Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul Asan medical Center | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41772803 | Derived | 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. |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Parallel Assignment
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| 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 |
|
| 48 hours |
| Proportion of rescue pain medication use | 48 hours |
| Total rescue pain medication use | 48 hours |