NCT06423703已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of Cebranopadol for the Treatment of Moderate to Severe Acute Pain After Primary Unilateral Bunionectomy
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
- 240
- 试验地点
- 10
- 主要终点
- Pain NRS area under the curve: cebranopadol vs. placebo
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Cebranopadol for acute pain after a bunionectomy.
详细描述
This study is a Phase 3, multicenter, randomized, double-blind, placebo- and active-controlled parallel-group study to evaluate the efficacy and safety of cebranopadol in the treatment of postoperative pain following primary unilateral bunionectomy with first metatarsal osteotomy. The study will be conducted in 3 phases: Screening, Treatment, and Follow-up.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Before Surgery:
- •Scheduled to undergo primary unilateral bunionectomy with first metatarsal osteotomy and internal fixation with no collateral procedures, using anesthesiologic and surgical procedures planned.
- •Must be able to adhere to the visit schedule, complete all study assessments and protocol requirements, including self-reported questionnaires.
排除标准
- •Before Surgery:
- •Any clinically significant disease, medical condition, or laboratory finding that in the investigator's opinion may interfere with the study procedures or data integrity, or compromise the safety of the subject.
- •Secondary (i.e., unrelated to bunion) current painful condition that could confound the interpretation of efficacy, safety, or tolerability data in the study, in the opinion of the investigator.
- •Subjects who require any analgesic for secondary (i.e., unrelated to bunion) painful condition that might impact the subject's ability to properly assess their postoperative pain, or that may require treatment during the Treatment Phase.
- •History of allergy or hypersensitivity to any opioid analgesics, anesthetics, ibuprofen, or other NSAIDs.
- •Immediate Postoperative Exclusion Criteria:
- •Surgical, postsurgical, or anesthetic complication that could confound the interpretation of efficacy, safety, or tolerability data in the study.
- •Deviation from the surgical, postsurgical, or anesthetic protocol that could confound the interpretation of efficacy, safety, or tolerability data in the study.
- •Evidence of hemodynamic instability or respiratory insufficiency.
研究组 & 干预措施
Oxycodone IR
Active Comparator
four times per day for 3 days
干预措施: Oxycodone IR (Drug)
Cebranopadol
Experimental
once daily for 3 days
干预措施: Cebranopadol (Drug)
Cebranopadol
Experimental
once daily for 3 days
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
four times per day for 3 days
干预措施: Placebo Only (Drug)
结局指标
主要结局
Pain NRS area under the curve: cebranopadol vs. placebo
时间窗: 2-48 hours
次要结局
- Proportion of subjects who require opioid rescue medication(1-7 Days)
- Global Assessment of Satisfaction(1-7 Days)
- Total oxycodone rescue consumption(1-7 Days)
研究者
研究点 (10)
Loading locations...
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