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)
12 de outubro de 2015 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
369
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Alabama
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Anniston, Alabama, Estados Unidos, 36207
- Site: 125
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California
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Fresno, California, Estados Unidos, 93720
- Site: 131
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Long Beach, California, Estados Unidos, 90806
- Site: 123
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Los Angeles, California, Estados Unidos, 90033
- Site: 116
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Orange, California, Estados Unidos, 92868
- Site: 112
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Walnut Creek, California, Estados Unidos, 94597
- Site: 130
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Connecticut
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Milford, Connecticut, Estados Unidos, 06460
- Site: 113
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New London, Connecticut, Estados Unidos, 06320
- Site: 119
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Florida
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Boynton Beach, Florida, Estados Unidos, 33435
- Site: 117
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Bradenton, Florida, Estados Unidos, 34205
- Site: 124
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Clearwater, Florida, Estados Unidos, 33765
- Site: 107
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Jupiter, Florida, Estados Unidos, 33458
- Site: 120
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Orlando, Florida, Estados Unidos, 32806
- Site: 108
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Oviedo, Florida, Estados Unidos, 32765
- Site: 132
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St. Petersburg, Florida, Estados Unidos, 33709
- Site: 127
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Tampa, Florida, Estados Unidos, 33606
- Site: 122
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Hawaii
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Honolulu, Hawaii, Estados Unidos, 96814
- Site: 133
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Massachusetts
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New Bedford, Massachusetts, Estados Unidos, 02740
- Site: 126
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48104
- Site: 115
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Missouri
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Hazelwood, Missouri, Estados Unidos, 63042
- Site: 128
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New York
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New York, New York, Estados Unidos, 10029
- Site:111
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North Carolina
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Winston-Salem, North Carolina, Estados Unidos, 27103
- Site: 110
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Ohio
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Kettering, Ohio, Estados Unidos, 45429
- Site: 121
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Texas
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Dallas, Texas, Estados Unidos, 75230
- Site:106
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Houston, Texas, Estados Unidos, 77030
- Site: 118
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Houston, Texas, Estados Unidos, 77098
- Site: 114
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Lubbock, Texas, Estados Unidos, 79410
- Site: 103
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San Antonio, Texas, Estados Unidos, 78228
- Site: 105
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San Antonio, Texas, Estados Unidos, 78229
- Site: 102
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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
Outros nomes:
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Comparador de Placebo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 8
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 12
Prazo: 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
Prazo: 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
Prazo: 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.
Prazo: 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.
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.
Prazo: 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
Prazo: 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
Prazo: 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.
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de fevereiro de 2012
Conclusão Primária (Real)
1 de fevereiro de 2014
Conclusão do estudo (Real)
1 de fevereiro de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
12 de fevereiro de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de fevereiro de 2012
Primeira postagem (Estimativa)
15 de fevereiro de 2012
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
4 de novembro de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de outubro de 2015
Última verificação
1 de outubro de 2015
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças do Sistema Nervoso
- Doenças do Sistema Endócrino
- Complicações do Diabetes
- Diabetes Mellitus
- Doenças Neuromusculares
- Doenças do Sistema Nervoso Periférico
- Neuropatias diabéticas
- Efeitos Fisiológicos das Drogas
- Agentes do Sistema Nervoso Periférico
- Agentes do Sistema Sensorial
- Agentes dermatológicos
- Antipruriginosos
- Capsaicina
Outros números de identificação do estudo
- E05-CL-3004
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .