Product Design Clinical Performance Study of sc2Wear Furosemide Combination Product
Open Label Study to Evaluate Product Design Clinical Performance of a To-Be-Marketed Drug-Device Combination Product (sc2Wear Furosemide Combination Product) in Subjects With Chronic Heart Failure
The proposed single-dose study aims to evaluate the product design clinical performance of the to-be-marketed drug-device combination product, the sc2Wear Furosemide Combination Product, in adult Subjects previously diagnosed with mild to advanced heart failure.
The study drug formulation is a buffered Furosemide Injection Solution, 8 mg/mL, (total dose equals 80 mg/mL) administered subcutaneously for a total of 5 hours. The study device is the sc2Wear Furosemide Pump adhered to the body using medical grade adhesive.
The objectives of this study are:
- To demonstrate that the to-be-marketed drug-device combination product performs as intended and delivers 80 mg of Furosemide subcutaneously in the abdominal area
- To assess safety and local tolerance of the drug-device combination product
研究概览
详细说明
This study will be an open label, single-dose study to evaluate product design clinical performance of a to-be-marketed drug-device combination product (sc2WearTM Furosemide Combination Product) in up to 70 adult male and female Subjects previously diagnosed with mild to advanced heart failure (NYHA Class II-IV). The study was designed and powered to achieve "95/95" performance testing. Methodology: Each Subject will complete Screening, Treatment, and Follow-Up Phases on an outpatient basis. During the Screening Phase, all Subjects who sign the informed consent form and satisfy the inclusion/exclusion criteria will be enrolled into the trial. Drug administration may start on the day of enrollment or be scheduled within 3 days of completion of Screening assessments. However, if the treatment visit doesn't occur within 3 days of initial screening, subjects may be rescreened and treated within 3 days of rescreening. The Treatment Phase comprises a preprogrammed bi-phasic 5 hour drug administration. Treatment Day observations will commence with pre-placement assessments and continue until after device removal. Device preparation, placement and removal will be performed by study staff in accordance with product instructions of use. Removal will occur within 3 hours of completion of drug delivery (8 hours of start of administration). Subjects will return 5-7 days after the Treatment Day for a post treatment follow-up and photography.
Blood samples will be obtained for the measurement of plasma furosemide levels prior to start of the administration and once during the plateau phase (1-5 hours following activation). After preparation of the skin the device will be placed on the upper abdominal area by clinical study staff. Subjects are advised to avoid strenuous physical activity or activities that could expose the device to moisture such as swimming, bathing or showering. Participants will be informed that marked diuresis may ensue after activation, and that they should avoid travel, operating a vehicle or other situations without immediate access to bathroom facilities. For this study, up to 70 unique reusable components (Activator) will be used. Likewise, up to 70 single-use units (Cartridge) will be used. Following removal from the skin, the assembled device will be inspected and photographed by the site staff. The used device (assembled Cartridge and Activator) will be placed in a sealed container and returned for further inspection and measurement of residual volume in the device reservoir by a qualified laboratory.
研究类型
注册 (实际的)
阶段
- 第三阶段
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
- Male and female Subjects ≥18 years of age
- New York Heart Association (NYHA) Class II-IV Heart Failure.
- In the opinion of the Investigator, able to participate in the study.
- If Subject is on oral diuretic, willing to suspend the oral furosemide or other loop diuretic treatment on the day of treatment (use of oral diuretic within 8 hours of start of treatment is not permitted).
- If Subject has significant body hair on the abdomen, willing to clip or shave the area where the device will be placed prior to treatment.
- Has the ability to understand the requirements of the study, and is willing to comply with all study procedures.
Exclusion Criteria:
- Contraindication to furosemide.
- History of chronic skin conditions requiring medical therapy.
- Skin reaction to medical adhesives or history of poor skin adherence of adhesives.
- Any local abdominal skin condition on the day of treatment i.e. sunburn, rash, eczema, etc.
- Diabetic patients currently using an insulin pump and/or interstitial glucose monitors.
- Clinically significant abnormalities at Screening in safety laboratory tests.
- Hypokalemia - Potassium of < 3.6 mmol/L.
- Systolic BP (SBP) < 90 mm Hg.
- Temperature > 38°C (oral or equivalent) or sepsis or active infection requiring IV anti-microbial treatment.
- History of major abdominal surgery affecting the site of device placement.
- Participation in another trial, within 30 days prior to Screening.
- History of hepatitis B, hepatitis C, or HIV
- Evidence of current or recent alcohol abuse.
- Female Subject who is pregnant or lactating.
- Any surgical or medical condition that -in the opinion of the Investigator - may interfere with participation in the study or that may affect the outcome of the study.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:sc2Wear 呋塞米组合产品
缓冲呋塞米注射液(速尿注射液)8 mg/mL 和贴剂泵(sc2Wear 速尿泵)的药物器械组合产品,用于在 5 小时内皮下给药 80 mg 剂量。
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缓冲呋塞米注射液(Furosemide Injection Solution)8 mg/mL和贴片泵(sc2Wear Furosemide Pump)的药物器械组合产品
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
无重大产品故障
大体时间:1-5小时
|
免于导致输液错误的故障。
|
1-5小时
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
局部疼痛耐受性
大体时间:1-5小时
|
受试者使用 0 到 10 的 11 点数字评定量表报告疼痛。
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1-5小时
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局部皮肤耐受性
大体时间:1-8天
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使用 8 点量表检查粘合部位皮肤是否有红斑、水肿和其他局部反应。
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1-8天
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治疗中出现的不良事件和严重不良事件的发生率
大体时间:1-8天
|
1-8天
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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sc2Wear 呋塞米的临床试验
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Todd M Koelling, MDscPharmaceuticals, Inc.撤销