- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00857623
Study to Evaluate the Analgesic Efficacy of 28 Days' Oral Administration of AZD2066 Compared With Placebo in Patients With Painful Diabetic Neuropathy
A Phase IIa, Double-Blind, Randomised, Parallel-Group, Multi-Centre Study to Evaluate the Analgesic Efficacy of 28 Days' Oral Administration of AZD2066 Compared With Placebo in Patients With Painful Diabetic Neuropathy
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Arkansas
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Bella Vista, Arkansas, Estados Unidos
- Reserach Site
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California
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National City, California, Estados Unidos
- Research Site
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Walnut Creek, California, Estados Unidos
- Research Site
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Florida
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Clearwater, Florida, Estados Unidos
- Research Site
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Deland, Florida, Estados Unidos
- Research Site
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Lauderdale Lakes, Florida, Estados Unidos
- Research Site
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Miami, Florida, Estados Unidos
- Research Site
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Orlando, Florida, Estados Unidos
- Research Site
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Pembroke Pines, Florida, Estados Unidos
- Research Site
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Kentucky
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Madisonville, Kentucky, Estados Unidos
- Research Site
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Maryland
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Owing Mills, Maryland, Estados Unidos
- Research Site
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Michigan
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Bingham Farms, Michigan, Estados Unidos
- Research Site
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New Jersey
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Willingboro, New Jersey, Estados Unidos
- Research Site
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New York
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Albany, New York, Estados Unidos
- Reasearch Site
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North Carolina
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Winston-Salem, North Carolina, Estados Unidos
- Research Site
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Pennsylvania
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Indiana, Pennsylvania, Estados Unidos
- Research Site
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Philadelphia, Pennsylvania, Estados Unidos
- Research Site
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Texas
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Houston, Texas, Estados Unidos
- Research Site
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San Antonio, Texas, Estados Unidos
- Research Site
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Provision of informed consent prior to any study specific procedures.
- Clinical diagnosis of painful diabetic neuropathy.
- non-fertile females
Exclusion Criteria:
- Other pain that may confound assessment of neuropathic pain.
- Ongoing significant peripheral arterial diseases, skin ulcers, or amputation in the lower extremities.
- History of psychotic disorders among first degree relatives.
Plan de estudios
¿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: 1
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Capsule, once daily, 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28.
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Comparador de placebos: 2
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Cápsula, una vez al día
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in Mean Numerical Rating Scale (NRS) Score From Baseline to Last 5 Days of Treatment
Periodo de tiempo: From baseline to day 28
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Change of mean pain intensity from 5-day baseline to the last 5 days of treatment, measured twice daily with NRS (12 hours recall). Mean pain intensity for 5-day baseline period (evening Day -6 to moning Day-1) and mean pain intensity for last 5 days on treatment (ie, last dose day and the 4 preceding calendar days) was calculated based on the numerical rating scale (NRS)(0-10). 0=No pain, 10=Worst pain imaginable. |
From baseline to day 28
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Daily Numerical Rating Scale (NRS) Pain Scores and Change From Baseline Over Time to Day 28.
Periodo de tiempo: From baseline to 28 days
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Mean pain intensity per day (mean of morning and evening NRS values) and change from baseline were calculated for each study day.
Baseline value= mean pain intensity for the 5-day baseline period.
NRS scale (0- 10) where 0= No pain and 10= Worst pain imaginable.
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From baseline to 28 days
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Number of Patients With >=30% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28
Periodo de tiempo: 28 days
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Pain intensity score reduction=(change from baseline at D28/baseline)*100 Responder= pain intensity score reduction ≥30% (yes/no)?
Responder rate= (no. of responders/total no. of patients)*100
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28 days
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Number of Patients With >=50% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28
Periodo de tiempo: 28 days
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Pain intensity score reduction= (change from baseline D28/baseline)*100 Responder=pain intensity score reduction ≥50% (Yes/No)?
Responder rate= (no. of responders/total no. of patients)*100
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28 days
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Number of Patients With Patient Global Impression of Change (PGIC) Score of at Least "Much Improved" at Day 28.
Periodo de tiempo: 28 days
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Patient Global Impression of Change (PGIC) scale ranges from 1-7, where 1= Very much improved and 7= Very much worse. Responder= Patient with a response of "much improved" or "very much improved" Responder rate= (no. of responders/total no. of patients)*100 |
28 days
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Change in McGill Pain Questionnaire Short Form (MPQ-SF) Sensory Index From Baseline to Day 28.
Periodo de tiempo: From baseline to day 28.
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Sensory index= sum of the intensity scale values of the words chosen for the descriptors 1-11 in the questionnaire. Range of scores for the sensory index= 0-33 (higher score represents a worse condition). Change from baseline (measured prior to randomization) to Day 28 was calculated. |
From baseline to day 28.
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Change in McGill Pain Questionnaire Short Form (MPQ-SF) Affective Index From Baseline to Day 28.
Periodo de tiempo: From baseline to day 28.
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Affective index= sum of the intensity scale values of the words chosen for the descriptors 12-15 in the questionnaire. Range of scores for the affective index=0-12 (higher score represents a worse condition). Change from baseline (measured prior to randomization) to Day 28 was calculated. |
From baseline to day 28.
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Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28.
Periodo de tiempo: From baseline to day 28..
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Change from baseline (measured prior to randomization) to Day 28 was calculated for the pain severity (mean of 4 intensity items).
Each intensity item is recorded on a Numerical rating Scale (NRS) 0-10, where 0=No pain and 10= The worst pain.
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From baseline to day 28..
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Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Interference From Baseline to Day 28.
Periodo de tiempo: From baseline to 28 days
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Change from baseline (measured prior to randomization) to Day 28 was calculated for pain interference (mean of 7 interference items).
Each interference item is recorded on a Numerical Rating Scale (NRS 0-10), where 0= No interference and 10= Interferes completely.
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From baseline to 28 days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Biljana Lilja, AstraZeneca R&D Södertälje151 85 Södertälje, Sweden
- Investigador principal: Charles E Argoff, MD, Albany Medical , NY 12208, USA
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- D0475C00009
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