Study of Duloxetine Versus Placebo in the Treatment of Fibromyalgia Syndrome
5 de novembro de 2007 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição
210
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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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
- 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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Ponce, Porto Rico
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San Juan, Porto Rico
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
O que o estudo está medindo?
Medidas de resultados primários
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 resultados secundários
Medida de resultado |
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Qualidade 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de junho de 2005
Conclusão do estudo (Real)
1 de junho de 2007
Datas de inscrição no estudo
Enviado pela primeira vez
12 de setembro de 2005
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de setembro de 2005
Primeira postagem (Estimativa)
19 de setembro de 2005
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
6 de novembro de 2007
Última atualização enviada que atendeu aos critérios de controle de qualidade
5 de novembro de 2007
Última verificação
1 de novembro de 2007
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças do Sistema Nervoso
- Doenças musculoesqueléticas
- Doenças Reumáticas
- Doenças Musculares
- Doenças Neuromusculares
- Fibromialgia
- Síndromes Dolorosas Miofasciais
- Efeitos Fisiológicos das Drogas
- Agentes Neurotransmissores
- Mecanismos Moleculares de Ação Farmacológica
- Agentes do Sistema Nervoso Periférico
- Analgésicos
- Agentes do Sistema Sensorial
- Drogas Psicotrópicas
- Inibidores de Captação de Neurotransmissores
- Moduladores de transporte de membrana
- Antidepressivos
- Agentes de Dopamina
- Inibidores da Recaptação de Serotonina e Noradrenalina
- Cloridrato de Duloxetina
Outros números de identificação do estudo
- 6222
- F1J-MC-HMCJ
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em placebo
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University of OxfordHospital General Universitario Gregorio Marañon; Charite University, Berlin,... e outros colaboradoresAinda não está recrutandoPsicose | Psicose Resistente ao TratamentoEspanha, Reino Unido, Alemanha, Israel, Grécia, Itália, Holanda, Suíça