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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
369
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Alabama
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Anniston、Alabama、アメリカ、36207
- Site: 125
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California
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Fresno、California、アメリカ、93720
- Site: 131
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Long Beach、California、アメリカ、90806
- Site: 123
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Los Angeles、California、アメリカ、90033
- Site: 116
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Orange、California、アメリカ、92868
- Site: 112
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Walnut Creek、California、アメリカ、94597
- Site: 130
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Connecticut
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Milford、Connecticut、アメリカ、06460
- Site: 113
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New London、Connecticut、アメリカ、06320
- Site: 119
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Florida
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Boynton Beach、Florida、アメリカ、33435
- Site: 117
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Bradenton、Florida、アメリカ、34205
- Site: 124
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Clearwater、Florida、アメリカ、33765
- Site: 107
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Jupiter、Florida、アメリカ、33458
- Site: 120
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Orlando、Florida、アメリカ、32806
- Site: 108
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Oviedo、Florida、アメリカ、32765
- Site: 132
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St. Petersburg、Florida、アメリカ、33709
- Site: 127
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Tampa、Florida、アメリカ、33606
- Site: 122
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Hawaii
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Honolulu、Hawaii、アメリカ、96814
- Site: 133
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Massachusetts
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New Bedford、Massachusetts、アメリカ、02740
- Site: 126
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Michigan
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Ann Arbor、Michigan、アメリカ、48104
- Site: 115
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Missouri
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Hazelwood、Missouri、アメリカ、63042
- Site: 128
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New York
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New York、New York、アメリカ、10029
- Site:111
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North Carolina
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Winston-Salem、North Carolina、アメリカ、27103
- Site: 110
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Ohio
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Kettering、Ohio、アメリカ、45429
- Site: 121
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Texas
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Dallas、Texas、アメリカ、75230
- Site:106
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Houston、Texas、アメリカ、77030
- Site: 118
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Houston、Texas、アメリカ、77098
- Site: 114
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Lubbock、Texas、アメリカ、79410
- Site: 103
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San Antonio、Texas、アメリカ、78228
- Site: 105
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San Antonio、Texas、アメリカ、78229
- Site: 102
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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
他の名前：
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プラセボコンパレーター：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 8
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 12
時間枠：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
時間枠：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
時間枠：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.
時間枠：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.
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
時間枠：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
時間枠：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
時間枠：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.
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2012年2月1日
一次修了 (実際)
2014年2月1日
研究の完了 (実際)
2014年2月1日
試験登録日
最初に提出
2012年2月12日
QC基準を満たした最初の提出物
2012年2月14日
最初の投稿 (見積もり)
2012年2月15日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年11月4日
QC基準を満たした最後の更新が送信されました
2015年10月12日
最終確認日
2015年10月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- E05-CL-3004
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。