NCT05509868已完成3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- SPID-48
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
PBK_L1704 0.35mg
Experimental
干预措施: PBK_L1704 0.35mg (Drug)
PBK_L1704 0.5mg
Experimental
干预措施: PBK_L1704 0.5mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
SPID-48
时间窗: 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).
次要结局
- 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)
研究者
研究点 (1)
Loading locations...
相似试验
撤回
3 期
802NP301 Efficacy and Safety Study of BIIB074 in Participants With Trigeminal NeuralgiaTrigeminal NeuralgiaNCT03070132Biogen
撤回
3 期
802NP302 Efficacy and Safety Study of BIIB074 in Participants With Trigeminal NeuralgiaTrigeminal NeuralgiaNCT03637387Biogen
终止
2 期
Efficacy and Safety Study of BIIB074 in Participants With Small Fiber NeuropathySmall Fiber NeuropathyDiabetes MellitusNCT03339336Biogen265
已完成
3 期
Safety and Efficacy Study of MK0974 in the Acute Migraine (0974-016)MigraineNCT00432237Merck Sharp & Dohme LLC1,703
已完成
3 期
A Study to Evaluate the Effectiveness and Safety of Slow Release Hydromorphone HCL for Treatment of Patients With OsteoarthritisOsteoarthritis, HipOsteoarthritis, KneeNCT00411164Alza Corporation, DE, USA990