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- Ensayo clínico NCT02490436
Novel Treatment Option for Neuropathic Pain (NoTOPain)
7 de noviembre de 2016 actualizado por: Sorlandet Hospital HF
A Randomized, Cross-over, Placebo-controlled, Double-blind, Single-center, Phase II Study of Cetuximab in Patients With Treatment-refractory, Non-malignant Severe Chronic Neuropathic Pain
The purpose of this study is to determine whether the EGFR-inhibitor cetuximab is better than placebo for the treatment of neuropathic pain.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
15
Fase
- Fase 2
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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-
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Kristiansand, Noruega, 4604
- Center for Cancer Treatment, Sorlandet Hospital HF
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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:
- Signed informed consent and anticipated compliance.
- Pain defined as "definite" neuropathic pain, according to the Special Interest Group on Neuropathic Pain guidelines or defined as "probable" NP, according to the guidelines, if the confirmatory test was a positive diagnostic test. Complex regional pain syndrome can be included despite lack of an offending lesion, as long as the "Budapest criteria" are fulfilled
- Neuropathic Pain associated with compressive nerve states (including failed surgery) or CRPS (according to the "Budapest criteria")
- PainDETECT score of at least 13 with average pain intensity of at least 6 /10 over the last four weeks. In addition, a painDETECT pattern indicating that the underlying neuropathic pain is constantly present.
- Worst pain intensity higher than 6 for five of seven days during the screening phase, according to Brif Pain Inventory.
- The patient should be able to distinguish between the neuropathic pain and other pain conditions, including elements of nociceptive pain caused by the same disease process.
- Neuropathic pain duration of between six and thirty months, deemed chronic and likely to be irreversible by clinical history and findings.
- No new or increased neuropathic pain treatment for the last four weeks.
- Standard medical treatments for the patients' underlying condition or neuropathic pain must have been considered or tried and must, according to the opinion of the referring or a consulted pain specialist, be judged to be inappropriate or of insufficient potential efficacy.
- Referring physician agreement to follow up the patient after study completion according to the best possible and available pain treatment and care.
- Women of childbearing potential and men must use an acceptable method of contraception throughout the study, and for 30 days after the last study drug administration.
- Negative pregnancy test within 7 days before each treatment period where appropriate.
- White blood cell count ≥ 3 × 109 with neutrophils ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L and hemoglobin ≥ 6.21 mmol/L (10 g/dL). Total bilirubin ≤ 1.5 × upper limit of reference range and AST and ALT ≤ 2.5 × upper limit of reference range within the last 28 days before inclusion.
- Aged 18 or above
Exclusion Criteria:
- Neuropathic pain origin in the central nervous system.
- Phantom limb pain or a significant component of nociceptive pain.
- Ascending distal small fiber peripheral neuropathy.
- Patients primarily experiencing pain 'attacks', i.e. pattern of neuropathic pain depicted in picture 3 of the painDETECT.
- Other pain state that may interfere with evaluation of the studied neuropathic pain condition.
- Any underlying medical or psychiatric condition, clinical disorder or laboratory finding, which in the opinion of the investigator may interfere with study objectives.
- Uncontrolled or unstable diabetes.
- Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV), unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias
- Severe cerebrovascular disease during the six months prior to inclusion.
- Active and ongoing eye and skin disorders or newly diagnosed gastric ulcer that may interfere with the study treatment.
- History of allergic reaction to any of the study treatment components, red meat or tick bites.
- Previous treatment with any EGFR-pathway inhibitor.
- Women who are pregnant or breastfeeding.
- Participation in another clinical trial within the past 90 days.
- Use of any investigational agent within 90 days prior to day 1 of study drug.
- Known drug abuse/alcohol abuse, legal incapacity or limited legal capacity or any other reason that, in the opinion of the investigator precludes the subject from participating.
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 cruzada
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: A: active drug first
Cetuximab in treatment period 1, placebo in treatment period 2, and open-label cetuximab in treatment period 3.
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Randomized cross-over between cetuximab and placebo
Otros nombres:
Randomized cross-over between cetuximab and placebo
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Experimental: B: placebo first
Placebo in treatment period 1, cetuximab in treatment period 2, and open-label cetuximab in treatment period 3.
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Randomized cross-over between cetuximab and placebo
Otros nombres:
Randomized cross-over between cetuximab and placebo
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Change in average neuropathic pain score using an 11-point numeric rating scale.
Periodo de tiempo: Days 4-8 after each infusion of cetuximab and placebo
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Days 4-8 after each infusion of cetuximab and placebo
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Comparison of frequency, in all patients on active treatment of at least a 30% reduction of average neuropathic pain score using an 11-point numeric rating scale.
Periodo de tiempo: Days 4-8 after each infusion of cetuximab and placebo
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Days 4-8 after each infusion of cetuximab and placebo
|
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Comparison of frequency in all patients on active treatment of at least a 50% reduction of average neuropathic pain score using an 11-point numeric rating scale.
Periodo de tiempo: Days 4-8 after each infusion of cetuximab and placebo
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Days 4-8 after each infusion of cetuximab and placebo
|
|
Comparison of change in average worst neuropathic pain score using an 11-point numeric rating scale.
Periodo de tiempo: Days 4-8 after each infusion of cetuximab and placebo
|
Days 4-8 after each infusion of cetuximab and placebo
|
|
Comparison of frequency, in all patients on active treatment of at least a 30% reduction of average worst neuropathic pain score using an 11-point numeric rating scale.
Periodo de tiempo: Days 4-8 after each infusion of cetuximab and placebo
|
Days 4-8 after each infusion of cetuximab and placebo
|
|
Comparison of frequency in all patients on active treatment of at least a 50% reduction of average worst neuropathic pain score using an 11-point numeric rating scale.
Periodo de tiempo: Days 4-8 after each infusion of cetuximab and placebo
|
Days 4-8 after each infusion of cetuximab and placebo
|
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Patient Global Impression of Change.
Periodo de tiempo: 7 days after each infusion.
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7 days after each infusion.
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Brief Pain Iinventory (short form) interference scores, comparing cetuximab to the placebo.
Periodo de tiempo: Days 4-8 after each infusion during treatment periods 1 and 2.
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Days 4-8 after each infusion during treatment periods 1 and 2.
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Brief Pain Iinventory (short form) total scores, comparing cetuximab to the placebo.
Periodo de tiempo: Days 4-8 after each infusion during treatment periods 1 and 2.
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Days 4-8 after each infusion during treatment periods 1 and 2.
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2-hourly waking time 11-point numeric rating scale (item #6 from the Brief Pain Inventory) in the first 24 hours and daily thereafter.
Periodo de tiempo: 2-hourly in first 24 hours after infusion and daily thereafter until end of study (day 86).
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2-hourly in first 24 hours after infusion and daily thereafter until end of study (day 86).
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Number of AE and SAE recording
Periodo de tiempo: From signing informed consent (within 28 days prior to first study treatment) and until 30 days after the last study infusion.
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From signing informed consent (within 28 days prior to first study treatment) and until 30 days after the last study infusion.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Christian Kersten, MD PhD, Center for Cancer Treatment, Sørlandet Hospital, Kristiansand
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.
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 octubre de 2015
Finalización primaria (Actual)
1 de octubre de 2016
Finalización del estudio (Actual)
1 de octubre de 2016
Fechas de registro del estudio
Enviado por primera vez
5 de junio de 2015
Primero enviado que cumplió con los criterios de control de calidad
2 de julio de 2015
Publicado por primera vez (Estimar)
3 de julio de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
8 de noviembre de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
7 de noviembre de 2016
Última verificación
1 de noviembre de 2016
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Dolor
- Manifestaciones neurológicas
- Enfermedades Neuromusculares
- Enfermedades del Sistema Nervioso Periférico
- Enfermedades del sistema nervioso autónomo
- Neuralgia
- Síndromes de dolor regional complejo
- Distrofia simpática refleja
- Agentes antineoplásicos
- Agentes antineoplásicos inmunológicos
- Cetuximab
Otros números de identificación del estudio
- SFK3 / 062202_281
- 2015-001195-21 (Número EudraCT)
- 2015/618/REK sør-øst D (Otro identificador: Regional Committees for Medical and Health Research Ethics)
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. .