Acute Pain Clinical Trial
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.
Status | Recruiting |
Enrollment | 225 |
Est. completion date | December 30, 2022 |
Est. primary completion date | December 26, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul Asan medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Pharmbio Korea Co., Ltd. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SPID-48 | Sum of Pain Intensity Differences (SPID) from baseline to 48 hours | 48 hours | |
Secondary | 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 | |
Secondary | Time to rescue pain medication use | 48 hours | ||
Secondary | Proportion of rescue pain medication use | 48 hours | ||
Secondary | Total rescue pain medication use | 48 hours |
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