Acute Pain
Conditions
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.
Interventions
DRUGPBK_L1704 0.35mg
The subject will receive PBK\_L1704 0.35mg/ml by PCA
DRUGPBK_L1704 0.5mg
The subject will receive PBK\_L1704 0.5mg/ml by PCA
DRUGPlacebo
The subject will receive placebo by PCA
Sponsors
Pharmbio Korea Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SPID-48 | 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
| Measure | Time frame | Description |
|---|---|---|
| Responder rate | 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. |
| Time to rescue pain medication use | 48 hours | — |
| Proportion of rescue pain medication use | 48 hours | — |
| Total rescue pain medication use | 48 hours | — |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORLee
Seoul Asan Medical Center
Outcome results
None listed