Study of Duloxetine Versus Placebo in the Treatment of Fibromyalgia Syndrome
5 de noviembre de 2007 actualizado por: Eli Lilly and Company
Dose Response Study of Duloxetine Versus Placebo in the Treatment of Fibromyalgia Syndrome
To assess the efficacy of Duloxetine compared with placebo in the treatment of pain in patients with Fibromyalgia syndrome, with or without major depressive disorder.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción
210
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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Arizona
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Peoria, Arizona, Estados Unidos
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Phoenix, Arizona, Estados Unidos
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Tucson, Arizona, Estados Unidos
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California
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Burbank, California, Estados Unidos
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Sherman Oaks, California, Estados Unidos
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Walnut Creek, California, Estados Unidos
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Connecticut
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Danbury, Connecticut, Estados Unidos
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Florida
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DeLand, Florida, Estados Unidos
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Ft. Myers, Florida, Estados Unidos
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Miami, Florida, Estados Unidos
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Indiana
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Lafayette, Indiana, Estados Unidos
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Kansas
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Prairie Village, Kansas, Estados Unidos
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Massachusetts
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Fall River, Massachusetts, Estados Unidos
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Springfield, Massachusetts, Estados Unidos
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Missouri
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St. Louis, Missouri, Estados Unidos
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New York
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Albany, New York, Estados Unidos
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North Carolina
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Greensboro, North Carolina, Estados Unidos
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Ohio
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Cincinnati, Ohio, Estados Unidos
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Cleveland, Ohio, Estados Unidos
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Toledo, Ohio, Estados Unidos
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Oregon
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Eugene, Oregon, Estados Unidos
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Portland, Oregon, Estados Unidos
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos
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Wyomissing, Pennsylvania, Estados Unidos
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Rhode Island
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Cranston, Rhode Island, Estados Unidos
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South Carolina
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Mt. Pleasant, South Carolina, Estados Unidos
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Myrtle Beach, South Carolina, Estados Unidos
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Texas
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Austin, Texas, Estados Unidos
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lake Jackson, Texas, Estados Unidos
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San Antonio, Texas, Estados Unidos
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Vermont
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Woodstock, Vermont, Estados Unidos
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Washington
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Kirkland, Washington, Estados Unidos
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Seattle, Washington, Estados Unidos
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Ponce, Puerto Rico
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San Juan, Puerto Rico
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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:
- Meet criteria for primary Fibromyalgia Syndrome as defined by the American College of Rheumatology
Exclusion Criteria:
- Have any current primary Axis I diagnosis other than major depressive disorder
- Have any current or previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder
- Have any primary diagnosis of anxiety disorder within the past year (including panic disorder, agoraphobia, OCD, PTSD, GAD and social phobia)
- Have regional pain syndrome, multiple surgeries or failed back syndrome
- Have a confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infective arthritis, or an autoimmune disease (e.g. lupus)
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: Doble
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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Assess efficacy of duloxetine versus placebo on the treatment of pain in patients with fibromyalgia syndrome
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Medidas de resultado secundarias
Medida de resultado |
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Calidad de vida
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Sheehan Disability Scale total score
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Average pain item of the BPI and the endpoint of the PGI-Improvement
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Reduction of pain severity
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Evaluate efficacy through the following: Fibromyalgia Impact Questionnaire, CGI-Severity, Tender-point pain thresholds, Multidimensional Fatigue Inventory, BPI average pain score, BPI severity and Interference scores
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Effect duloxetine on pain is independent of MDD or mood improvement
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Assess safety of duloxetine
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
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.
Publicaciones Generales
- Mease PJ, Spaeth M, Clauw DJ, Arnold LM, Bradley LA, Russell IJ, Kajdasz DK, Walker DJ, Chappell AS. Estimation of minimum clinically important difference for pain in fibromyalgia. Arthritis Care Res (Hoboken). 2011 Jun;63(6):821-6. doi: 10.1002/acr.20449.
- Russell JI, Mease PJ, Smith TR, Kajdasz DK, Wohlreich MM, Detke MJ, Walker DJ, Chappell AS, Arnold LM. Efficacy and safety of duloxetine for treatment of fibromyalgia in patients with or without major depressive disorder: Results from a 6-month, randomized, double-blind, placebo-controlled, fixed-dose trial. Pain. 2008 Jun;136(3):432-444. doi: 10.1016/j.pain.2008.02.024. Epub 2008 Apr 18.
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 junio de 2005
Finalización del estudio (Actual)
1 de junio de 2007
Fechas de registro del estudio
Enviado por primera vez
12 de septiembre de 2005
Primero enviado que cumplió con los criterios de control de calidad
12 de septiembre de 2005
Publicado por primera vez (Estimar)
19 de septiembre de 2005
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
6 de noviembre de 2007
Última actualización enviada que cumplió con los criterios de control de calidad
5 de noviembre de 2007
Última verificación
1 de noviembre de 2007
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Enfermedades musculoesqueléticas
- Enfermedades reumáticas
- Enfermedades Musculares
- Enfermedades Neuromusculares
- Fibromialgia
- Síndromes de dolor miofascial
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Agentes del sistema nervioso periférico
- Analgésicos
- Agentes del sistema sensorial
- Drogas psicotropicas
- Inhibidores de la captación de neurotransmisores
- Moduladores de transporte de membrana
- Agentes antidepresivos
- Agentes de dopamina
- Inhibidores de la recaptación de serotonina y noradrenalina
- Clorhidrato de duloxetina
Otros números de identificación del estudio
- 6222
- F1J-MC-HMCJ
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. .