NCT01533428已完成3 期
A Phase III, Double-blind, Randomized, Placebo-controlled, Multicenter Study Evaluating the Efficacy and Safety of QUTENZA® in Subjects With Painful Diabetic Peripheral Neuropathy
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
- 369
- 试验地点
- 29
- 主要终点
- Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 8
研究概览
简要总结
The purpose of the study is to assess efficacy and safety of a single treatment of Capsaicin 8% transdermal delivery system in reducing pain from damaged nerves (neuropathic pain) caused by diabetes.
详细描述
Participants were divided into 2 groups of approximately equal size. In the first group, participants received a Capsaicin 8% patch applied for 30 minutes to the feet; in the second group, participants received a placebo patch applied for 30 minutes to the feet. Participants were involved in the study for approximately 12 weeks and have visited the clinic approximately 6 times.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to diabetes, for at least 1 year prior to screening visit
- •Average Numeric Pain Rating Scale (NPRS) score over the last 24 hours of ≥4 at the screening and the baseline visit
排除标准
- •Primary pain associated with PDPN (Painful Diabetic Peripheral Neuropathy) in the ankles or above
- •Pain that could not be clearly differentiated from, or conditions that might interfere with the assessment of PDPN (Painful Diabetic Peripheral Neuropathy), neurological disorders unrelated to diabetic neuropathy (e.g., phantom limb pain from amputation); skin condition in the area of the neuropathy that could alter sensation (e.g., plantar ulcer)
- •Current or previous foot ulcer as determined by medical history and medical examination
- •Any amputation of lower extremity
- •Severe renal disease as defined by a creatinine clearance of <30 ml/min calculated according to the Cockcroft-Gault formula
- •Clinically significant cardiovascular disease within 6 months prior to screening visit defined as cerebrovascular accident, unstable or poorly controlled hypertension, transient ischemic attack, myocardial infarction, unstable angina, current arrhythmia, any heart surgery including coronary artery bypass graft surgery, percutaneous coronary angioplasty/stent placement, or valvular heart disease
- •Significant peripheral vascular disease (intermittent claudication or lack of pulsation of either the dorsalis pedis or posterior tibial artery, or ankle-brachial systolic blood pressure index of <0.80)
- •Clinically significant foot deformities, including hallux rigidus, hallux valgus, or rigid toe as determined by physical examination as judged by the investigator
- •Clinically significant ongoing, uncontrolled or untreated abnormalities in cardiac, renal, hepatic, or pulmonary function that may interfere either with the ability to complete the study or the evaluation of adverse events
- •Diagnosis of any poorly controlled major psychiatric disorder
- •Active substance abuse or history of chronic substance abuse within 1 year prior to screening visit or any prior chronic substance abuse (including alcoholism) likely to re-occur during the study period as judged by the investigator
- •Hypersensitivity to capsaicin (i.e., chili peppers or over-the-counter [OTC] capsaicin products), any Capsaicin 8% transdermal delivery system excipients, Eutectic Mixture of Local Anaesthetics (EMLA) ingredients or adhesives
- •Use of any topical pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics, steroids or capsaicin products on the painful areas within 7 days preceding the first patch application at the baseline visit
- •Use of oral or transdermal opioids exceeding a total daily dose of morphine of 80 mg/day, or equivalent; or any parenteral opioids, regardless of dose, within 7 days preceding the first patch application at the baseline visit
- •Skin areas to be treated with Capsaicin 8% transdermal delivery system showing changes such as crusting or ulcers
- •Planned elective surgery during the trial
研究组 & 干预措施
Capsaicin 8%
Experimental
Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
干预措施: Capsaicin 8% (Drug)
Placebo
Placebo Comparator
Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 8
时间窗: Baseline to between Weeks 2 to 8
Percent change in the average daily pain score from baseline to between Weeks 2 and 8, measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).
次要结局
- Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Scale From Baseline to Weeks 2, 8 and 12(Baseline to Weeks 2, 8 and 12)
- Percentage of Participants With 50% Reduction in Average Daily Pain Score.(Baseline, Weeks 2-8 and Weeks 2-12)
- Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 2(Baseline to Week 2)
- Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 12(Baseline to Week 12)
- Weekly Average of Average Daily Pain at Baseline and Every Week After Baseline(Baseline and Weeks 2, 4, 8 and 12)
- Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 8(Baseline to Week 8)
- Change in Hospital Anxiety and Depression Scale (HADS) Depression Scale From Baseline to Weeks 2, 8 and 12.(Baseline to Weeks 2, 8 and 12)
- Tolerability of Patch Application Assessed by Dermal Assessment on Day 1, 15 Minutes and 60 Minutes After Patch Removal.(Day 1, 15 minutes and 60 minutes after patch removal)
- Safety Assessed Through Adverse Events (AE) and Serious Adverse Events (SAE), Vital Signs, and Laboratory Analyses From Baseline to Week 12(Baseline to Week 12)
- Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 12(Baseline to between Weeks 2 and 12)
- Percentage of Participants With 30% Reduction in Average Daily Pain Score.(Baseline, Weeks 2-8 and Weeks 2-12)
- Percent Change in Average Sleep Interference Score From Baseline to Between Weeks 2-8 and Weeks 2-12(Baseline, Weeks 2-8 and Weeks 2-12)
- Number of Participants Who Used Rescue Pain Medication Days 1 Through 5(Days 1 - 5)
- Weekly Percent Change From Baseline in Average Daily Pain Score(Baseline to Weeks 2, 3, 4, 5, 6, 7, 8, 9,10, 11 and 12)
- Change From Baseline in the European Quality Of Life (QOL) Questionnaire in 5 Dimensions (EQ-5D) With Visual Analog Scale (VAS) to Weeks 2, 8 and 12(Baseline to Weeks 2, 8 and 12)
- Treatment Satisfaction Assessment Based on Self-Assessment of Treatment (SAT II) Questionnaire at Baseline, Weeks 8 and 12(Baseline, Weeks 8 and 12)
- Change From Pre-application in"Pain Now" Score(Pre-application and 15 minutes and 60 minutes after patch removal)
研究者
研究点 (29)
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