Phase 2 Herniorrhaphy Study for Opioid Elimination
赞助:
Heron Therapeutics
合作者:
信息的提供 (责任方):
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| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | October 1, 2018 | ||
| 首次发布日期e ICMJE | October 4, 2018 | ||
| 最后更新发布日期 | October 5, 2018 | ||
| 预计研究开始日期 ICMJE | October 1, 2018 | ||
| 预计主要完成日期 | December 2018 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Proportion of subjects receiving no opioid rescue[ Time Frame: 72 hours ] |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Phase 2 Herniorrhaphy Study for Opioid Elimination | ||
| 正式标题 ICMJE | A Phase 2, Open-Label Study of HTX 011 in a Multimodal Analgesic Regimen for Decreased Opioid Use Following Unilateral Open Inguinal Herniorrhaphy | ||
| 简要概况 | This is a Phase 2, open-label study in subjects undergoing unilateral open inguinal herniorrhaphy. |
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| 详细说明 | |||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 2 | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Prevention |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
30 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | January 2019 | ||
| 预计主要完成日期 | December 2018 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Is scheduled to undergo a unilateral open inguinal herniorrhaphy with mesh under general anesthesia. - Has an American Society of Anesthesiologists Physical Status of I, II, or III. - Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives. Exclusion Criteria: - Had any prior inguinal hernia repair except as a child (less than 6 years of age). - Has a planned concurrent surgical procedure (eg, bilateral herniorrhaphy). - Has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain. - Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications. - Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months. - Has taken any NSAIDs within least 10 days prior to the scheduled surgery. - Has taken long-acting opioids within 3 days prior to the scheduled surgery. - Has taken any opioids within 24 hours prior to the scheduled surgery. - Has been administered bupivacaine within 5 days prior to the scheduled surgery. - Has been administered any local anesthetic within 72 hours prior to the scheduled surgery. - Has initiated treatment with study medications within 1 month prior to study drug administration that can impact pain control. - Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug. - Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments. - As per subject history and/or medical records, has active infection or is currently undergoing treatment for Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV). - Has uncontrolled anxiety, psychiatric, or neurological disorder. - Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix. - Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse. Note: Subjects with a positive drug screen who are taking an allowed, prescribed medication that is known to result in a positive drug test (eg, amphetamine and dextroamphetamine for attention-deficit/hyperactivity disorder, benzodiazepine for anxiety disorder) may be eligible for participation in the study at the discretion of the Sponsor. Subjects taking any marijuana (medical or recreational) are not allowed to participate in the study. - Previously participated in an HTX-011 study. - Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives. - Has undergone 3 or more surgeries within 12 months. - Has a body mass index (BMI) >39 kg/m2. | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | ||
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: Yes 研究涉及美国FDA监管的设备产品: Yes |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | Heron Therapeutics | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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