Study To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing In Patients With Neuropathic Pain
11 de abril de 2019 actualizado por: Pfizer
A Randomized, Double Blind, Placebo Controlled, 2-Way Crossover Methodology Study Designed To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing (QST) In Patients With Neuropathic Pain Treated With Pregabalin Vs Placebo
Conventional pain efficacy measures such as Visual Analogue Scores (VAS) are often unable to detect treatment efficacy in small-scale clinical trials.
Combining conventional pain efficacy measures with quantitative sensory testing (QST) may provide more sensitive and informative outcome measures in clinical trials.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Methodology to assess reproducibility and sensitivity of quantitative sensory testing
Tipo de estudio
Intervencionista
Inscripción (Actual)
31
Fase
- No aplica
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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Vienna, Austria, A-1090
- Pfizer Investigational Site
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Bruxelles, Bélgica, 1070
- Pfizer Investigational Site
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Boulogne Billancourt, Francia, 92100
- Pfizer Investigational Site
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Liverpool, Reino Unido, L9 7AL
- Pfizer Investigational Site
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London, Reino Unido, SW10 9NH
- Pfizer Investigational Site
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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:
- Neuropathic pain of peripheral origin demonstrating spontaneous ongoing pain and dynamic mechanical allodynia to brush stimuli.
- A present pain intensity score of 4 or more (out of 10) for spontaneous ongoing pain and brush-evoked allodynia at the skin area at screen.
- Stable analgesic medication (excluding pregabalin) for a minimum of 1 month prior to the start of study.
Exclusion Criteria:
- Patients who have undergone neurolytic or neurosurgical therapy.
- Patients who have trigeminal neuralgia, central pain (due to cerebrovascular lesions, multiple sclerosis and traumatic spinal cord injuries), complex regional pain syndrome (Type I and II), and phantom limb pain.
- Patients who have previously been treated with pregabalin.
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: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador de placebos: Placebo
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BID dosing for 28 days
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Comparador activo: Droga activa
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Dose titration according to following regimen: 75mg BID for 3 days; 150mg for 4 days; 225mg BID for 4 days; 300mg BID for 17 days.
Dose reduced for renally impaired patients
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Mean Change From Baseline in Dynamic Allodynia Intensity at Visits 3 and 6 and Visits 4 and 7
Periodo de tiempo: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
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Five strokes applied with a standardized brush (somedic) across the painful site, 6cm long and at a control site to allow the participants to appreciate any difference.
A painful and clearly dysaesthetic (unpleasant) sensation was considered as representing brush allodynia (whereas a "strange" or "tickly" sensation provoked by the brush was not).
After each brush stimuli participants were asked to give a pain rating using 11-point numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable.
The average of 5 brush strokes was calculated to obtain the mean score.
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Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
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Mean Change From Baseline in Dynamic Allodynia Area at Visits 3 and 6 and Visits 4 and 7
Periodo de tiempo: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
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Dynamic area brush in cm^2: calculated from 8 measured distances by calculating the area of an octagon.
The angle between each pair of lines was 45 degrees at point c.
The area of the octagon was found by totaling the areas of the 8 triangles.
Octagon with 8 radial lengths from center to the outside.
Area = Σ ( ½ length * perpendicular height); Σ ( ½ ri * sin(45) r(i+1) ) = Σ ( (ri * r(i+1) )/2√2)).
(where ri, i=1 to 8, were the eight radial lengths)
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Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
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Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7
Periodo de tiempo: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
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Sensitivity to mechanical pain stimuli was tested using calibrated Von Frey monofilaments.
To obtain a stimulus-response-function, seven different Von Frey monofilaments (size 8 to 512 mN, force increased by a factor of two from filament to filament) applied three times each; each stimulus was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable.
If a score of 8 or more was reported for a given intensity no stronger stimuli was applied.
Von Frey stimulus was applied to the skin for 1 to 2 seconds.
The average of 3 ratings was calculated for the mean score.
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Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
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Mean Change From Baseline in Punctate Allodynia Area (Von Frey) at Visits 3 and 6 and Visits 4 and 7
Periodo de tiempo: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
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Punctate allodynia area in cm^2: calculated from 8 measured distances by calculating the area of an octagon.
The angle between each pair of lines was 45 degrees at point c.
The area of the octagon was found by totaling the areas of the 8 triangles.
Octagon with 8 radial lengths from center to the outside.
Area = Σ ( ½ length * perpendicular height); Σ ( ½ ri * sin(45) r(i+1) ) = Σ ( (ri * r(i+1) )/2√2)).
(where ri, i=1 to 8, were the eight radial lengths)
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Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
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Mean Change From Baseline in Cold Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7
Periodo de tiempo: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
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Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 5 degrees celsius for cold stimuli (between 5 and 20 degrees celsius).
Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable.
The average of 2 ratings was calculated to get the mean score.
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Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
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Mean Change From Baseline in Heat Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7
Periodo de tiempo: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
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Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 4 degrees celsius for heat stimuli (between 40 and 50 degrees celsius).
Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable.
The average of 2 ratings was calculated to get the mean score.
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Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Mean Change From Baseline in Weekly Pain Score From the Daily Diary at Visits 3 and 6 and Visits 4 and 7
Periodo de tiempo: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
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Daily pain diary: participant-rated pain during the past 24 hours rated on an 11 point NRS scale where 0=no pain and 10=worst possible pain.
For a given week, the pain response was the average of the 7 daily entries for that week, or average of the available data for that week if fewer than 7 entries were recorded (>=1 daily pain score for any given week required).
The endpoint for each week consisted of the change from baseline in average pain score (follow-up value minus baseline).
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Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
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Mean Change From Baseline in Patient's Global Impression of Change (PGIC) at Visits 3 and 6 and Visits 4 and 7
Periodo de tiempo: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
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PGIC: participant-rated assessment measuring change in participant's overall status on a 7-point scale from 1=very much improved to 7=very much worse.
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Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
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Mean Change From Baseline in Test-Day Global Pain Intensity at Visits 3 and 6 and Visits 4 and 7
Periodo de tiempo: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
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Global pain: participant-rated pain using the test-day global pain scale, consisting of an 11-point NRS where 0 = no pain and 10 = worst possible pain.
Participants described intensity of pain in response to "How intense is your pain today?"
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Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
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Mean Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Visits 4 and 7
Periodo de tiempo: Week 4 (Visits 4 and 7) of each period
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NPSI: 10-item self-administered questionnaire assessing 5 dimensions of pain (burning superficial spontaneous pain, pressing deep spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia).
Each item consists of a question about the specific qualities of pain and an 11-point numerical scale range: 0 (absence of pain) to 10 (maximum intensity imaginable), and 2 temporal items related to spontaneous and paroxysmal pain.
Maximum total score possible = 100.
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Week 4 (Visits 4 and 7) of each period
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
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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 diciembre de 2006
Finalización primaria (Actual)
1 de septiembre de 2009
Finalización del estudio (Actual)
1 de septiembre de 2009
Fechas de registro del estudio
Enviado por primera vez
4 de mayo de 2010
Primero enviado que cumplió con los criterios de control de calidad
4 de mayo de 2010
Publicado por primera vez (Estimar)
5 de mayo de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
23 de abril de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
11 de abril de 2019
Última verificación
1 de abril de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Dolor
- Manifestaciones neurológicas
- Enfermedades Neuromusculares
- Enfermedades del Sistema Nervioso Periférico
- Neuralgia
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Depresores del sistema nervioso central
- Agentes del sistema nervioso periférico
- Analgésicos
- Agentes del sistema sensorial
- Agentes tranquilizantes
- Drogas psicotropicas
- Moduladores de transporte de membrana
- Agentes contra la ansiedad
- Anticonvulsivos
- Hormonas y agentes reguladores del calcio
- Bloqueadores de los canales de calcio
- Pregabalina
Otros números de identificación del estudio
- A9011015
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. .