A Study to Evaluate Efficacy and Safety of a Single Application of Capsaicin 8%Transdermal Delivery System Compared to Placebo in Reducing Pain Intensity in Subjects With Painful Diabetic Peripheral Neuropathy (PDPN) (STEP)
2015年10月12日 更新者：Astellas Pharma Inc
A Phase III, Double-blind, Randomized, Placebo-controlled, Multicenter Study Evaluating the Efficacy and Safety of QUTENZA® in Subjects With Painful Diabetic Peripheral Neuropathy
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
369
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Alabama
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Anniston、Alabama、美国、36207
- Site: 125
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California
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Fresno、California、美国、93720
- Site: 131
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Long Beach、California、美国、90806
- Site: 123
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Los Angeles、California、美国、90033
- Site: 116
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Orange、California、美国、92868
- Site: 112
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Walnut Creek、California、美国、94597
- Site: 130
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Connecticut
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Milford、Connecticut、美国、06460
- Site: 113
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New London、Connecticut、美国、06320
- Site: 119
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Florida
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Boynton Beach、Florida、美国、33435
- Site: 117
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Bradenton、Florida、美国、34205
- Site: 124
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Clearwater、Florida、美国、33765
- Site: 107
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Jupiter、Florida、美国、33458
- Site: 120
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Orlando、Florida、美国、32806
- Site: 108
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Oviedo、Florida、美国、32765
- Site: 132
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St. Petersburg、Florida、美国、33709
- Site: 127
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Tampa、Florida、美国、33606
- Site: 122
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Hawaii
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Honolulu、Hawaii、美国、96814
- Site: 133
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Massachusetts
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New Bedford、Massachusetts、美国、02740
- Site: 126
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Michigan
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Ann Arbor、Michigan、美国、48104
- Site: 115
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Missouri
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Hazelwood、Missouri、美国、63042
- Site: 128
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New York
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New York、New York、美国、10029
- Site:111
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North Carolina
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Winston-Salem、North Carolina、美国、27103
- Site: 110
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Ohio
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Kettering、Ohio、美国、45429
- Site: 121
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Texas
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Dallas、Texas、美国、75230
- Site:106
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Houston、Texas、美国、77030
- Site: 118
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Houston、Texas、美国、77098
- Site: 114
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Lubbock、Texas、美国、79410
- Site: 103
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San Antonio、Texas、美国、78228
- Site: 105
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San Antonio、Texas、美国、78229
- Site: 102
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Capsaicin 8%
Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
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Capsaicin 8% transdermal delivery system
其他名称：
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安慰剂比较：Placebo
Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
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Placebo Patch
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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 |
|---|---|---|
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Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 8
大体时间：Baseline to between Weeks 2 to 8
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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).
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Baseline to between Weeks 2 to 8
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 12
大体时间：Baseline to between Weeks 2 and 12
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Percent Change in the Average Daily Pain Score from baseline to between Weeks 2 and 12 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).
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Baseline to between Weeks 2 and 12
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Weekly Percent Change From Baseline in Average Daily Pain Score
大体时间：Baseline to Weeks 2, 3, 4, 5, 6, 7, 8, 9,10, 11 and 12
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Weekly Percent Change from baseline in average daily pain score from baseline to Week 12 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).
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Baseline to Weeks 2, 3, 4, 5, 6, 7, 8, 9,10, 11 and 12
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Weekly Average of Average Daily Pain at Baseline and Every Week After Baseline
大体时间：Baseline and Weeks 2, 4, 8 and 12
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Weekly average of average daily pain score at Baseline and Weeks 2,4,8 and 12 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).
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Baseline and Weeks 2, 4, 8 and 12
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Percentage of Participants With 30% Reduction in Average Daily Pain Score.
大体时间：Baseline, Weeks 2-8 and Weeks 2-12
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Percentage of participants achieving 30% decrease in the average daily pain score in Weeks 2 and 8 and Weeks 2 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN).
Participants assessed their pain on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).
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Baseline, Weeks 2-8 and Weeks 2-12
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Percentage of Participants With 50% Reduction in Average Daily Pain Score.
大体时间：Baseline, Weeks 2-8 and Weeks 2-12
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Percentage of participants achieving 50% decrease in the average daily pain score in Weeks 2 and 8 and Weeks 2 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN).
Participants assessed their pain on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).
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Baseline, Weeks 2-8 and Weeks 2-12
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Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 2
大体时间：Baseline to Week 2
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Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in Week 2
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Baseline to Week 2
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Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 8
大体时间：Baseline to Week 8
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Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in Week 8
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Baseline to Week 8
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Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 12
大体时间：Baseline to Week 12
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Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in Week 12
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Baseline to Week 12
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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
大体时间：Baseline to Weeks 2, 8 and 12
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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. EQ-5D self-reported questionnaire is used to measure health-related quality of life by measuring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
The EQ-5D questionnaire includes a visual analog scale (VAS) which records participants self-rated health status on a graduated (0-100) scale with higher scores indicating higher Health-Related Quality of Life (HRQoL).
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Baseline to Weeks 2, 8 and 12
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Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Scale From Baseline to Weeks 2, 8 and 12
大体时间：Baseline to Weeks 2, 8 and 12
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The Hospital Anxiety and Depression Scale (HADS) is a self-report scale developed for the assessment of anxiety and depression, that contain 14 items rated on a 4-point Likert-type scale.
There are 2 subscales,one assessing depression and the other anxiety.
The 7-item depression and anxiety subscales yield scores of 0 to 21 that are interpreted with the following cut-off points: 0 to 7, normal; 8 to 10, mild mood disturbance; 11 to 14, moderate mood disturbance; and 15 to 21, severe mood disturbance.
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Baseline to Weeks 2, 8 and 12
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Change in Hospital Anxiety and Depression Scale (HADS) Depression Scale From Baseline to Weeks 2, 8 and 12.
大体时间：Baseline to Weeks 2, 8 and 12
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The Hospital Anxiety and Depression Scale (HADS) is a self-report scale developed for the assessment of anxiety and depression, it contains 14 items rated on a 4-point Likert-type scale.
There are 2 subscales,one assessing depression and the other anxiety.
The 7-item depression and anxiety subscales yield scores of 0 to 21 that are interpreted with the following cut-off points: 0 to 7, normal; 8 to 10, mild mood disturbance; 11 to 14, moderate mood disturbance; and 15 to 21, severe mood disturbance.
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Baseline to Weeks 2, 8 and 12
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Treatment Satisfaction Assessment Based on Self-Assessment of Treatment (SAT II) Questionnaire at Baseline, Weeks 8 and 12
大体时间：Baseline, Weeks 8 and 12
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Treatment satisfaction assessment based on Self-Assessment Treatment (SAT II) questionnaire and the question "Over the past 7 days, how much has the study treatment improved your pain level?"
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Baseline, Weeks 8 and 12
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Percent Change in Average Sleep Interference Score From Baseline to Between Weeks 2-8 and Weeks 2-12
大体时间：Baseline, Weeks 2-8 and Weeks 2-12
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Percent change in average sleep interference was measured by Question 9F of the Brief Pain Inventory-Diabetic Neuropathy (BPI DN) and was used to assess pain and sleep interference index.
Daily sleep interference rating scale consists of an 11-point numerical scale with which the patient describes how pain related to diabetes has interfered with their sleep during the past 24 hours.
On a scale 0 identifies "pain does not interfere with sleep" and 10 identifies "pain completely interferes with sleep".
Average sleep interference score is assessed from baseline to Weeks 2-8 and Weeks 2-12.
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Baseline, Weeks 2-8 and Weeks 2-12
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Tolerability of Patch Application Assessed by Dermal Assessment on Day 1, 15 Minutes and 60 Minutes After Patch Removal.
大体时间：Day 1, 15 minutes and 60 minutes after patch removal
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Tolerability of patch application was assessed by dermal assessment (0 to 7 point severity score on Dermal Assessment Scale).
Data reported is based on the number of participants in the combined category with a score ≥ 4 (Definite edema or higher), 15 and 60 minutes after patch removal.
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Day 1, 15 minutes and 60 minutes after patch removal
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Change From Pre-application in"Pain Now" Score
大体时间：Pre-application and 15 minutes and 60 minutes after patch removal
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Change from pre-application in"Pain Now" score was measured on a scale from 0-10 where 0 equates to "No Pain" and 10 to "Pain as bad as you can imagine".
Participants were asked to provide pain ratings relative only to the area of pain undergoing treatment.
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Pre-application and 15 minutes and 60 minutes after patch removal
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Number of Participants Who Used Rescue Pain Medication Days 1 Through 5
大体时间：Days 1 - 5
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Summarized number of participants who used Rescue Pain Medications for Pain
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Days 1 - 5
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Safety Assessed Through Adverse Events (AE) and Serious Adverse Events (SAE), Vital Signs, and Laboratory Analyses From Baseline to Week 12
大体时间：Baseline to Week 12
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Number of patients assessed for Safety through Adverse Events (AE) and Serious Adverse Events (SAE), vital signs, and laboratory analyses from baseline to week 12
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Baseline to Week 12
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年2月1日
初级完成 (实际的)
2014年2月1日
研究完成 (实际的)
2014年2月1日
研究注册日期
首次提交
2012年2月12日
首先提交符合 QC 标准的
2012年2月14日
首次发布 (估计)
2012年2月15日
研究记录更新
最后更新发布 (估计)
2015年11月4日
上次提交的符合 QC 标准的更新
2015年10月12日
最后验证
2015年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.