A Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy of CHADD™ Applied Over a Transdermal Fentanyl Patch for the Treatment of Breakthrough Pain in Patients With Moderate to Severe Non-malignant Chronic Pain
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 109
- 试验地点
- 15
- 主要终点
- Patient's rating of pain intensity (NRS), the patient's evaluation of pain relief using a 5-point verbal rating scale (VRS), and the patient's global satisfaction assessment.
研究概览
简要总结
A multi-center study to evaluate the efficacy of CHADD (Controlled Heat-Assisted Drug Delivery) applied over a 50 mcg/hr ZR-02-01 matrix transdermal fentanyl patch for the treatment of breakthrough pain in adult patients with moderate to severe non-malignant chronic pain. The open-label study arm will last up to 12 days. The double-blind arm will last up to 15 days. Eligible patients who complete the open-label arm will be allowed to enroll in the double-blind study arm.
详细描述
ZARS Pharma is developing a Matrix Transdermal Fentanyl/CHADD (Controlled Heat-Assisted Drug Delivery) Drug Delivery System to be used for the treatment of chronic and breakthrough pain. The Matrix Transdermal Fentanyl/CHADD Drug Delivery System has been designed to provide long-term delivery of fentanyl for the treatment of chronic pain as well as intermittent increases in fentanyl concentrations for the treatment of breakthrough pain. Breakthrough pain is defined as a transitory exacerbation of pain that occurs on a background of otherwise stable pain in a patient receiving chronic opioid therapy.
Matrix Transdermal Fentanyl/CHADD Drug Delivery System has 2 components: a matrix transdermal fentanyl patch (the ZR-02-01 patch in doses of 25, 50, 75 and 100 mcg/hr) with corresponding thin film dressing (ie, overlay) and the CHADD (Controlled Heat-Assisted Drug Delivery).
The matrix transdermal fentanyl patch provides a continuous delivery of fentanyl over 72 hours, in a manner similar to Duragesic®. During a breakthrough pain episode, a CHADD unit is placed over (adhered to) the matrix transdermal fentanyl patch. The CHADD is a thin patch-like chemical heating device that generates a controlled level of heat for approximately 15-20 minutes. The application of heat delivers increased amounts of fentanyl when applied over the ZR-02-01 matrix transdermal fentanyl patch.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is 18 through 70 years of age.
- •Patient has moderate to severe non-malignant chronic pain.
- •Patient is opioid-tolerant, requires treatment with chronic opioids and is currently taking a dose of 50 mcg/hr transdermal fentanyl for the treatment of chronic pain. Patient must have been taking this dose for at least 2 weeks.
- •Patient must be experiencing 1 to 4 episodes of target breakthrough pain (breakthrough pain that is related to the patient's chronic pain condition) a day while taking a dose of 50 mcg/hr transdermal fentanyl.
排除标准
- •Patient has active cancer.
- •Patient has a history of substance abuse or has a substance abuse disorder.
- •Patient is pregnant or breastfeeding.
研究组 & 干预措施
50 mcg/hr matrix fentanyl patch
active 50 mcg/hr ZR-02-01 matrix transdermal fentanyl patch (20 cm2)
干预措施: Matrix Transdermal Fentanyl/CHADD Drug Delivery System (Drug)
Placebo Patch
placebo (20 cm2) will be indistinguishable in size, shape, and appearance to the active matrix fentanyl patch
干预措施: Placebo Patch (Drug)
结局指标
主要结局
Patient's rating of pain intensity (NRS), the patient's evaluation of pain relief using a 5-point verbal rating scale (VRS), and the patient's global satisfaction assessment.
时间窗: 0, 15, 20, 60 minutes
Efficacy will be evaluated by the patient's rating of pain intensity using an 11-point numerical rating scale (NRS), the patient's evaluation of pain relief using a 5-point verbal rating scale (VRS), and the patient's global satisfaction assessment.
次要结局
- Adhesion assessment(3 days)
- Pain Relief(15, 30, 60 minutes)
- Patient's Global Satisfaction Assessment(60 minutes)
- Number of participants with adverse events(15 days)