- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01533428
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 octubre de 2015 actualizado 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Actual)
369
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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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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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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
Otros nombres:
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Comparador de placebos: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 8
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 12
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de febrero de 2012
Finalización primaria (Actual)
1 de febrero de 2014
Finalización del estudio (Actual)
1 de febrero de 2014
Fechas de registro del estudio
Enviado por primera vez
12 de febrero de 2012
Primero enviado que cumplió con los criterios de control de calidad
14 de febrero de 2012
Publicado por primera vez (Estimar)
15 de febrero de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
4 de noviembre de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
12 de octubre de 2015
Última verificación
1 de octubre de 2015
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Enfermedades del sistema endocrino
- Complicaciones de la diabetes
- Diabetes mellitus
- Enfermedades Neuromusculares
- Enfermedades del Sistema Nervioso Periférico
- Neuropatías diabéticas
- Efectos fisiológicos de las drogas
- Agentes del sistema nervioso periférico
- Agentes del sistema sensorial
- Agentes dermatológicos
- Antipruriginosos
- Capsaicina
Otros números de identificación del estudio
- E05-CL-3004
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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