- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02554552
Clinical Trial of YY1201 for Treatment of Osteoarthritis of the Knee
A Multicenter, Randomized, Double-blinded, Parallel, Placebo-controlled, Phase I/IIa Clinical Trial to Evaluate the Efficacy and Safety of Intra-articular YY1201 Once in the Treatment of Patients With Osteoarthritis of the Knee
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Estágio
- Fase 2
- Fase 1
Contactos e Locais
Locais de estudo
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-
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Seoul, Republica da Coréia
- Samsung Medical Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Males or Females 40 years and older
According to the clinical diagnosis standard of the American College of Rheumatology (ACR), someone, diagnosed as a single/both sides of osteoarthritis, who corresponds to over 3 conditions of followings.
- Over 50 years of age
- Less than 30 minutes of morning stiffness
- Crepitus on active motion
- 4 bony tenderness
- Bony enlargement
- Nopalpable warmth of synvium
- Within 6 months from screening visit, someone who diagnosed with Kellgren & Lawrence Grade I~III by the radioactive examination.
- By the Weight-bearing pain(100mm-VAS) examination, someone who has a outcome of the single or both sides of the osteoarthritis is over 40mm
- Patient (No-responder) who has experienced steady pain in spite of dosing NSAIDs or other pain-killers in the past.
- Patient who can walk by themselves without helper like cane or walker etc. (If the patient who has used helper routinely from previous 6 months, evaluating the patient including the helper is possible. In this case, patient needs to use same helper continuously by end of the clinical trial test.)
- Patient who agrees to participate in this clinical trial by themselves.
Exclusion Criteria:
- Someone who has BMI≥32kg/m² at the screening visit.
- Patient who has an experience dosing psychoactive drug, narcotic analgesic which can have an effect on pain sense over 3 months habitually.
- Patient who has been administrated gastrointestinal drug(for example H₂-blockers, misoprostol or proton pump inhibitors) regularly, who can't stop injecting for clinical study period.
- Patient has attended abnormal values from screening test(2 times excess at upper limit of the normal values at ALT, AST, BUN, Serum Creatinine).
- Patient who has rheumarthritis or other inflammatory metabolic arthritis.
- Patients having serious gastrointestinal, liver, renal, heart disease.
- When the inflammatory disease is occurred on joint area to patient like septic arthritis.
- Patients having skin ailment at the injecting site of the joint region.
- Patients having secondary osteoarthritis according to the Ochronosis, Hemochromatosis or systemic disease.
- Patients who have severe pain like Sudek's atrophy, Paget's disease, Spinal disc herniation.
- Poly-articular patients who have suffered seriously by osteoarthritis at other parts affect judge of the knee joint pain.
- Patients who diagnosed clear interval disappearance at the knee joint by X-ray.
Patients who were administrated below drugs before baseline visit.
- Patients who were injected HA at the target knee joint in recent 9 months.
- Patients who were injected HA at other parts of the knee joint in recent 6 months.
- Patients who were injected steroids into the intra-articular knee joint.
- Patients who were administrated steroids systemically by the oral medication (But, except inhalation)
- Patients who have joint effusion trouble were judged as a positive by tests like Patella tap test.
- Patients who have target knee joint gotten surgical operation history including Arthroscopy within past one year (In case of having other side of knee joint or hip joint gotten surgical operation history, excepting the patients if there is possibility which can influence the target knee joint's appraisal.
- Patients who have an operation history about target knee joint.
- Patients who do the height weight aerobic exercise or anaerobic exercise.
- Patients who need to be administrated anticoagulant agent together(But, except 300mg daily dose aspirin)
- Patients who have hypersensitivity history about Investigational Product.
In the midst of women in their childbearing years, patients who disagree to do * contraception by medically permitted method for 12 weeks from administrating investigational product.
* The contraception by medically permitted method: Condom, In case of using injection or insertion, In case of installing a intrauterine contraception device etc.
- Patients who were injected other investigational product over a time within 30 days before participated in this clinical trail.
- Besides that, the patients who have difficulty to be participated in this clinical trial continuously by Principle Investigator (PI)'s decision.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: YY1201 2ml
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YY1201 2ml
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Experimental: YY1201 3ml
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YY1201 2ml
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Comparador de Placebo: Placebo 2ml
Phosphate buffered saline 2ml
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phosphate buffered saline 2ml
Outros nomes:
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Comparador de Placebo: Placebo 3ml
Soro fisiológico tamponado com fosfato 3ml
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solução salina tamponada com fosfato 3ml
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Variation of the Weight-bearing pain(100mm-VAS) on the 4, 12 weeks after administration in comparison with baseline
Prazo: Week 4 and Week 12
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Week 4 and Week 12
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Variation of the KOOS scales on the 4, 12 weeks after administration in comparison with baseline
Prazo: Week 4 and Week 12
|
Week 4 and Week 12
|
Variation of the rest pain(100mm-VAS) on the 4, 12 weeks after administration in comparison with baseline
Prazo: Week 4 and Week 12
|
Week 4 and Week 12
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Dor de movimento (100mm-VAS) nas 4, 12 semanas após a administração em comparação com a linha de base
Prazo: Semana 4 e Semana 12
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Semana 4 e Semana 12
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Avaliação global do paciente (100 mm-VAS) nas 4, 12 semanas após a administração com linha de base
Prazo: Semana 4 e Semana 12
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Semana 4 e Semana 12
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Avaliação global do investigador (100 mm-VAS) nas 4, 12 semanas após a administração
Prazo: Semana 4 e Semana 12
|
Semana 4 e Semana 12
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Alteração do inchaço na articulação do joelho desde o início até 4, 12 semanas após a administração
Prazo: Semana 4 e Semana 12
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Semana 4 e Semana 12
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Alteração da sensibilidade à pressão na articulação do joelho desde o início até 4, 12 semanas após a administração
Prazo: Semana 4 e Semana 12
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Semana 4 e Semana 12
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Rate of change of the Range Of Motion(ROM) in the knee joint on 4, 12 weeks after administration with baseline
Prazo: Week 4 and Week 12
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Week 4 and Week 12
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Contagem de uso de medicação de resgate e quantidade total em 4, 12 semanas
Prazo: Semana 4 e Semana 12
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Semana 4 e Semana 12
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Taxa de resposta da dor de sustentação de peso em 12 semanas em comparação com a linha de base
Prazo: Semana 12
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Semana 12
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Taxa de resposta do OMERACT-OARSI em 12 semanas em comparação com a linha de base
Prazo: Semana 12
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Semana 12
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Chul-Won Ha, M.D., Samsung Medical Center, Department of Internal Medicine
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- YY_YY1201_001/2a
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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 .
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