NCT07845071招募中3 期
An Open-Label, Single-Arm, Multiple-Dose, Phase 3 Safety and Efficacy Study of Cebranopadol in Participants With Moderate to Severe Acute Pain With Surgical or Non-Surgical Origin
Adneuris Therapeutics, Inc.15 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 15
- 主要终点
- Sum of pain intensity differences through 48 hours (SPID48)
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of cebranopadol in treating acute pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adults 18 to 75 years of age.
- •Able to provide informed consent.
- •Experiencing moderate to severe acute pain related to: 1) An ambulatory surgical procedure expected to cause pain lasting at least 72 hours, or 2) A traumatic or non-traumatic musculoskeletal condition.
- •Have a pain score of at least 4 on a 0 to 10 pain rating scale before starting study treatment.
- •Willing and able to comply with study requirements
排除标准
- •Chronic pain condition that requires ongoing pain medication.
- •Significant medical or psychiatric condition that could affect participation or study results.
- •History of substance use disorder or misuse of alcohol or drugs.
- •Current use of medications that may interfere with the study drug or pain assessments.
- •Known allergy or intolerance to cebranopadol or permitted rescue pain medications.
- •Pregnant or breastfeeding.
- •Participation in another clinical trial or receipt of an investigational drug within the protocol-defined period before study entry.
- •Any condition that, in the investigator's opinion, would make participation unsafe or interfere with study assessments.
研究组 & 干预措施
Cebranopadol
Experimental
Participants receive Cebranopadol 400 µg Starting dose 400 mcg once per day for 14 days or until pain resolves, whichever occurs first.
干预措施: Cebranopadol 400 ug (Drug)
结局指标
主要结局
Sum of pain intensity differences through 48 hours (SPID48)
时间窗: From 0 through 48 hours
Sum of pain intensity differences through 48 hours (SPID48), calculated from NPRS assessments collected following the first administration of cebranopadol.
次要结局
未报告次要终点
研究者
研究点 (15)
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