A Study Comparing Duloxetine and Placebo in the Treatment of Fibromyalgia
28 de mayo de 2010 actualizado por: Eli Lilly and Company
Flexible Dosed Duloxetine Versus Placebo in the Treatment of Fibromyalgia
The purpose of this study is to confirm the efficacy and safety of duloxetine 60-120 mg once daily in comparison to placebo on symptom improvement in patients meeting criteria for fibromyalgia aged 18 and older.
Patients will be randomized to duloxetine or placebo, however, all patients will receive duloxetine at some point in the study.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
530
Fase
- Fase 4
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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Phoenix, Arizona, Estados Unidos, 85050
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Tucson, Arizona, Estados Unidos, 85741
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California
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Los Angeles, California, Estados Unidos, 90024
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Pasadena, California, Estados Unidos, 91105
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Connecticut
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Cromwell, Connecticut, Estados Unidos, 06416
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Danbury, Connecticut, Estados Unidos, 06810
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Florida
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Bradenton, Florida, Estados Unidos, 34208
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Deland, Florida, Estados Unidos, 32720
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Fort Myers, Florida, Estados Unidos, 33912
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Orlando, Florida, Estados Unidos, 32806
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South Miami, Florida, Estados Unidos, 33143
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Tampa, Florida, Estados Unidos, 33606
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West Palm Beach, Florida, Estados Unidos, 33407
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Illinois
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Oak Brook, Illinois, Estados Unidos, 60523
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Indiana
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Lafayette, Indiana, Estados Unidos, 47905
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Kansas
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Prairie Village, Kansas, Estados Unidos, 66206
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Maryland
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Rockville, Maryland, Estados Unidos, 20852
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Massachusetts
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Belmont, Massachusetts, Estados Unidos, 02478
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Fall River, Massachusetts, Estados Unidos, 02721
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Newton, Massachusetts, Estados Unidos, 02462
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Springfield, Massachusetts, Estados Unidos, 01103
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48104
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Missouri
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St Louis, Missouri, Estados Unidos, 63141
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New Jersey
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Edison, New Jersey, Estados Unidos, 08817
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Piscataway, New Jersey, Estados Unidos, 08854
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North Carolina
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Greensboro, North Carolina, Estados Unidos, 27408
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45219
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Toledo, Ohio, Estados Unidos, 43623
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73109
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Oregon
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Eugene, Oregon, Estados Unidos, 97404
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Portland, Oregon, Estados Unidos, 97210
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19107
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South Carolina
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Myrtle Beach, South Carolina, Estados Unidos, 29572
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Texas
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Dallas, Texas, Estados Unidos, 75231
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Lake Jackson, Texas, Estados Unidos, 77566
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San Antonio, Texas, Estados Unidos, 78229
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Waco, Texas, Estados Unidos, 76708
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Wichita Falls, Texas, Estados Unidos, 76309
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Utah
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West Jordan, Utah, Estados Unidos, 84088
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Washington
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Bellevue, Washington, Estados Unidos, 98007
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Seattle, Washington, Estados Unidos, 98104
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Tacoma, Washington, Estados Unidos, 98405
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Wisconsin
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Middleton, Wisconsin, Estados Unidos, 53562
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Hato Rey, Puerto Rico, 00918
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Ponce, Puerto Rico, 00716
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San Juan, Puerto Rico, 00935
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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:
- male or female patients
- aged 18 and older who meet criteria for fibromyalgia as defined by the American College of Rheumatology
- have a score of at least 4 on the average pain item of the Brief Pain Inventory (BPI) (modified short form) at visits 1 and 2
- all females must test negative for pregnancy at the time of enrollment
- have a degree of understanding such that the patient can provide informed consent, complete protocol required assessments and communicate intelligibly with the investigator and study coordinator.
Exclusion Criteria:
- have pain symptoms related to traumatic injury, structural rheumatic disease, or regional rheumatic disease that will interfere with interpretation of outcome measures
- have regional pain syndrome, multiple surgeries or failed back syndrome
- have confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an autoimmune disease (i.e. systemic lupus erythematosus)
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: Duloxetine
60-120 mg, oral, every day, 12 weeks
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60-120 mg, oral, every day, 12 weeks (acute blinded phase followed by a 12 week blinded continuation phase).
Otros nombres:
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Comparador de placebos: Placebo
oral, daily, 12 weeks
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oral, daily, 12 weeks (acute blinded phase followed by 12 weeks of blinded duloxetine treatment)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Patient's Global Impressions of Improvement (PGI-I) at Week 12
Periodo de tiempo: 12 weeks
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The PGI-Improvement scale is a patient-rated instrument that measures perceived improvement in symptoms.
It is a 7-point scale where a score of 1 indicates that the patient is "very much improved," a score of 4 indicates that the patient has experienced "no change," and a score of 7 indicates that the patient is "very much worse."
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12 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change From Baseline in Brief Pain Inventory (BPI) (Modified Short Form) at 12 Week Endpoint
Periodo de tiempo: Baseline, 12 weeks
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BPI is a self-reported form that assesses severity of pain and the interference of pain on function.
There are 4 questions assessing the severity for worst pain, least pain, and average pain in the past 24 hours, and the pain right now.
Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine).
There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
Interference scores range from 0 (does not interfere) to 10 (completely interferes).
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Baseline, 12 weeks
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Change From Baseline in Multidimensional Fatigue Inventory (MFI) at 12 Week Endpoint
Periodo de tiempo: Baseline, 12 weeks
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MFI is a 20-item, self-reporting instrument designed to collect data on the following 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity.
Each dimension score is derived by summing the scores of the 4 individual items that pertain to each dimension.
Item scores range from 1 to 5; thus, dimensional scores range from 4 to 20 with a higher score reflecting greater levels of fatigue.
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Baseline, 12 weeks
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Change From Baseline in Beck Depression Inventory-II (BDI-II) at 12 Week Endpoint
Periodo de tiempo: Baseline, 12 weeks
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BDI-II is a 21-item patient-completed questionnaire designed to assess characteristics of depression.
Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme).
This questionnaire will be used to rate the severity of depressive symptoms and any improvement during the course of the trial.
The total score ranges from 0 to 63; the higher the score, the more severe the depressive symptoms.
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Baseline, 12 weeks
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Change From Baseline in Clinical Global Impressions of Severity (CGI-S) at 12 Week Endpoint
Periodo de tiempo: Baseline, 12 Weeks
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The Clinical Global Impressions of Severity (CGI-Severity) scale evaluates the severity of illness at the time of assessment.
The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
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Baseline, 12 Weeks
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Change From Baseline in Beck Anxiety Inventory (BAI) at 12 Week Endpoint
Periodo de tiempo: Baseline, 12 weeks
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BAI is a 21-item patient-completed questionnaire designed to assess characteristics of anxiety.
Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme).
This questionnaire will be used to rate the severity of anxiety symptoms and any improvement during the course of the trial.
The total score ranges from 0 to 63; the higher the score, the more severe the anxiety symptoms.
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Baseline, 12 weeks
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Change From Baseline in 36-Item Short-form Health Survey (SF-36) at 12 Weeks
Periodo de tiempo: Baseline, 12 weeks
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The patient-rated SF-36 consists of 36 questions covering eight health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality.
Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning.
Two summary scores: the Physical Component Summary and the Mental Component Summary are constructed based on the eight SF-36 domains.
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Baseline, 12 weeks
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Change From Baseline in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total Score at 12 Week Endpoint
Periodo de tiempo: Baseline, 12 weeks
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The MGH-CPFQ is a self-report instrument consisting of seven questions pertaining to an individual's cognitive and physical well-being.
Each question is rated 1 = "greater than normal" to 6 = "totally absent".
Total score ranges from 7 to 42.
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Baseline, 12 weeks
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Change From Baseline in the Mood, Anxiety, Pain, Sleep, and Stiffness Likert Scale at 12 Week Endpoint
Periodo de tiempo: Baseline, 12 weeks
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Likert scales are patient-rated assessments.
Mood: feeling low, sad or depressed; rated 0 = not feeling low, sad or depressed to 10 = feeling extremely low, sad or depressed.
Anxious: anxious feelings; rated 0 = not feeling anxious to 10 = extremely anxious.
Sleep: how much patient bothered by sleep difficulties; rated 0 = not bothered to 10 = extremely bothered.
Pain: how much patient bothered by painful physical discomforts; rated 0 = not bothered to 10 = extremely bothered.
Stiffness: how stiff patient felt in past 24 hours; rated 0 = not felt any stiffness to 10 = felt extremely stiff.
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Baseline, 12 weeks
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Number of Responders: 30% Improvement in Brief Pain Inventory Average Pain at 12 Week Endpoint
Periodo de tiempo: 12 Weeks
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Response was defined as at least 30% reduction from baseline to endpoint (last observation carried forward) for BPI average pain score.
BPI average pain score assesses the severity of the average pain in the past 24 hours.
The average severity score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).
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12 Weeks
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Number of Responders: 50% Improvement in Brief Pain Inventory Average Pain Score at 12 Week Endpoint
Periodo de tiempo: 12 weeks
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Response was defined as at least 50% reduction from baseline to endpoint (last observation carried forward) for BPI average pain score.
BPI average pain score assesses the severity of the average pain in the past 24 hours.
The average severity score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).
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12 weeks
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Change From Baseline in Blood Pressure at 12 Week Endpoint
Periodo de tiempo: Baseline, 12 weeks
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Baseline, 12 weeks
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Change From Baseline in Heart Rate at 12 Week Endpoint
Periodo de tiempo: Baseline, 12 weeks
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Baseline, 12 weeks
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Number of Patients With Columbia Suicide Severity Rating Scale (CSSR-S) Events (Behaviors, Ideations, Acts)
Periodo de tiempo: Baseline through 12 Weeks
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C-SSRS: scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors.
Number of patients with suicidal behaviors, ideations, and acts are provided.
Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.
Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation.
Suicidal act: a "yes" answer to actual attempt or completed suicide.
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Baseline through 12 Weeks
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Change From Baseline in Weight at 12 Week Endpoint
Periodo de tiempo: Baseline, 12 weeks
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Baseline, 12 weeks
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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
- Mohs R, Mease P, Arnold LM, Wang F, Ahl J, Gaynor PJ, Wohlreich MM. The effect of duloxetine treatment on cognition in patients with fibromyalgia. Psychosom Med. 2012 Jul-Aug;74(6):628-34. doi: 10.1097/PSY.0b013e31825b9855. Epub 2012 Jun 28.
- Arnold LM, Wang F, Ahl J, Gaynor PJ, Wohlreich MM. Improvement in multiple dimensions of fatigue in patients with fibromyalgia treated with duloxetine: secondary analysis of a randomized, placebo-controlled trial. Arthritis Res Ther. 2011 Jun 13;13(3):R86. doi: 10.1186/ar3359.
- Arnold LM, Clauw D, Wang F, Ahl J, Gaynor PJ, Wohlreich MM. Flexible dosed duloxetine in the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled trial. J Rheumatol. 2010 Dec;37(12):2578-86. doi: 10.3899/jrheum.100365. Epub 2010 Sep 15.
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 junio de 2008
Finalización primaria (Actual)
1 de abril de 2009
Finalización del estudio (Actual)
1 de julio de 2009
Fechas de registro del estudio
Enviado por primera vez
5 de mayo de 2008
Primero enviado que cumplió con los criterios de control de calidad
6 de mayo de 2008
Publicado por primera vez (Estimar)
7 de mayo de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
24 de junio de 2010
Última actualización enviada que cumplió con los criterios de control de calidad
28 de mayo de 2010
Última verificación
1 de mayo de 2010
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
- 12220 (Otro identificador: Company Internal)
- F1J-US-HMGB (Otro identificador: Eli Lilly and Company)
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. .