- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00421928
Tapentadol (CG5503)
16 de abril de 2012 atualizado por: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Randomized Double-Blind, Placebo- and Active-Control, Parallel-arm, Phase III Trial With Controlled Adjustment of Dose to Evaluate the Efficacy and Safety of CG5503 Extended-Release (ER) in Patients With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
The purpose of this trial is to evaluate the effectiveness (level of pain control) and safety of orally administered tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250 mg twice daily in patients with moderate to severe chronic pain due to osteoarthritis of the knee, in comparison with placebo and Oxycodone Controlled Release (CR).
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
The primary objective of this randomized (study medication assigned to patients by chance), double-blind (neither patient nor investigator knows the study medication) , phase III, placebo and active controlled trial is to evaluate the efficacy and safety of orally administered tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250 mg twice daily in patients with moderate to severe chronic pain from osteoarthritis (OA) of the knee.
The study is being conducted for registration and approval of tapentadol (CG5503) in the US and outside the US.
The trial will consist of five periods: screening (to assess eligibility) , washout (3-7 days with determination of a baseline pain intensity), titration (of dose over 3 weeks to the optimal individual level) , maintenance (investigational drug intake for 12 weeks with adjustments allowed), and follow-up (2 weeks post treatment discontinuation).
The study hypothesis is that the study drug will be more effective than placebo in reducing patients pain intensity.
The Secondary objectives include the collection of pharmacokinetic (related to how the body uses the drug) information for dose verification.
The trial objectives will be assessed by comparing the baseline pain level to the level of week 12 of the maintenance phase.
This will be done by looking at the patient's pain diary information.
Titrate tapentadol (CG5503) ER (extended release) 50mg to patient's optimal dose ranging between 100mg and 250mg twice a day; Oxycodone CR (controlled release) 10mg to 50mg twice a day; Placebo (no active ingredients).
All doses of trial treatment will be taken orally with approximately 120 mL of water with or without food for a maximum timeframe of 15 weeks.
Tipo de estudo
Intervencional
Inscrição (Real)
1030
Estágio
- Fase 3
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
40 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Patients diagnosed with osteoarthritis of the knee based on the American College of Rheumatology (ACR) criteria and functional capacity class of I-III
- patients taking analgesic medications for at least 3 months prior to screening and/or dissatisfied with their current therapy
- Patients requiring opioid treatment must be taking daily doses of opioid-based analgesic, equivalent to <160 mg of oral morphine
- baseline score of greater than or equal to 5 on an 11-point numerical rating scale, calculated as the average pain intensity during the last 3 days prior to randomization.
Exclusion Criteria:
- History of alcohol and/or drug abuse in Investigator's judgement
- history of significant liver insufficiency
- chronic hepatitis B or C, or HIV, presence of active hepatitis B or C within the past 3 months
- life-long history of seizure disorder or epilepsy
- history of malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated
- uncontrolled hypertension
- patients with severely impaired renal function
- patients with moderate to severly impaired hepatic function or with laboratory values reflecting inadequate hepatic function
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: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: 001
tapentadol (CG5503) 50 100 150 200 250mg twice a day (BID) during 15 weeks
|
50, 100, 150, 200, 250mg twice a day (BID) during 15 weeks
|
Comparador Ativo: 002
oxycodone 10 20 30 40 50mg twice a day (BID) during 15 weeks
|
10, 20, 30, 40, 50mg twice a day (BID) during 15 weeks
|
Comparador de Placebo: 003
placebo matching placebo twice a day (BID) during 15 weeks
|
matching placebo twice a day (BID) during 15 weeks
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12.
Prazo: Baseline and 12 weeks (Primary endpoint is the average pain intensity score during the last week of the maintenance period).
|
For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
|
Baseline and 12 weeks (Primary endpoint is the average pain intensity score during the last week of the maintenance period).
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Change From Baseline in Western Ontario McMaster Questionnaire (WOMAC) Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week of the Maintenance Period at Week 12
Prazo: Baseline and 12 week endpoint
|
Change from baseline to Week 12 of WOMAC Global Score: WOMAC is measure with a Likert ordinal scale from 0-4 with lower scores indicating lower levels of symptoms or physical disability
|
Baseline and 12 week endpoint
|
Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12.
Prazo: Baseline and 12 week endpoint
|
A Sleep Questionniare addressed the following question: "How long after bedtime/lights out did you fall asleep last night (hours)?" 12 week endpoint-mean changes from baseline at endpoint for sleep latency.
Decrease in time(hours) indicates improvement.
|
Baseline and 12 week endpoint
|
Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12
Prazo: Baseline and 12 week endpoint
|
Ordinal measure indicating change from start of treatment (on a scale of 7 = Very much worse to 1 = Very much improved)
|
Baseline and 12 week endpoint
|
Distribution of Time to Treatment Discontinuation Due to Lack of Efficacy
Prazo: Baseline to 12 weeks
|
The median time to treatment discontinuation due to lack of efficacy from baseline to endpoint
|
Baseline to 12 weeks
|
Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to Week 12
Prazo: Baseline and 12 week endpoint
|
Change from baseline to end point in EuroQol-5 (EQ-5D) Dimension Questionnaire.
A higher score indicates an improvement in health in the Health Status Index.
The EQ-5D is a five dimensional health state classification.
Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems).
The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead
|
Baseline and 12 week endpoint
|
Change From Baseline in Responder Analysis 50% Improvement to Week 12
Prazo: Baseline and Week 12
|
Defined by the percentage of subjects achieving at least 50% improvement from baseline in the primary endpoint based on the 11-point NRS at week 12.
For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
|
Baseline and Week 12
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
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
- Etropolski M, Kuperwasser B, Flugel M, Haufel T, Lange B, Rauschkolb C, Laschewski F. Safety and tolerability of tapentadol extended release in moderate to severe chronic osteoarthritis or low back pain management: pooled analysis of randomized controlled trials. Adv Ther. 2014 Jun;31(6):604-20. doi: 10.1007/s12325-014-0128-6. Epub 2014 Jul 2.
- Afilalo M, Morlion B. Efficacy of tapentadol ER for managing moderate to severe chronic pain. Pain Physician. 2013 Jan;16(1):27-40.
- Biondi DM, Xiang J, Etropolski M, Moskovitz B. Evaluation of blood pressure and heart rate in patients with hypertension who received tapentadol extended release for chronic pain: a post hoc, pooled data analysis. Clin Drug Investig. 2014 Aug;34(8):565-76. doi: 10.1007/s40261-014-0209-y.
- Etropolski M, Lange B, Goldberg J, Steup A, Rauschkolb C. A pooled analysis of patient-specific factors and efficacy and tolerability of tapentadol extended release treatment for moderate to severe chronic pain. J Opioid Manag. 2013 Sep-Oct;9(5):343-56. doi: 10.5055/jom.2013.0177.
- Merchant S, Provenzano D, Mody S, Ho KF, Etropolski M. Composite measure to assess efficacy/gastrointestinal tolerability of tapentadol ER versus oxycodone CR for chronic pain: pooled analysis of randomized studies. J Opioid Manag. 2013 Jan-Feb;9(1):51-61. doi: 10.5055/jom.2013.0147.
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 janeiro de 2007
Conclusão Primária (Real)
1 de julho de 2008
Conclusão do estudo (Real)
1 de dezembro de 2008
Datas de inscrição no estudo
Enviado pela primeira vez
12 de janeiro de 2007
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de janeiro de 2007
Primeira postagem (Estimativa)
15 de janeiro de 2007
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
18 de abril de 2012
Última atualização enviada que atendeu aos critérios de controle de qualidade
16 de abril de 2012
Última verificação
1 de abril de 2012
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças articulares
- Doenças musculoesqueléticas
- Doenças Reumáticas
- Artrite
- Osteoartrite
- Osteoartrite, Joelho
- Efeitos Fisiológicos das Drogas
- Agentes Adrenérgicos
- Agentes Neurotransmissores
- Mecanismos Moleculares de Ação Farmacológica
- Depressores do Sistema Nervoso Central
- Agentes do Sistema Nervoso Periférico
- Analgésicos
- Agentes do Sistema Sensorial
- Analgésicos, Opioides
- Narcóticos
- Inibidores de Captação de Neurotransmissores
- Moduladores de transporte de membrana
- Inibidores da Captação Adrenérgica
- Oxicodona
- Tapentadol
Outros números de identificação do estudo
- CR013402
- R331333PAI3008 (Outro identificador: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)
- KF11 (Outro identificador: Grunenthal GMBH)
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 tapentadol (CG5503)
-
Johnson & Johnson Pharmaceutical Research & Development...Concluído
-
Johnson & Johnson Pharmaceutical Research & Development...Grünenthal GmbHConcluído
-
Johnson & Johnson Pharmaceutical Research & Development...Concluído
-
Johnson & Johnson Pharmaceutical Research & Development...Concluído
-
Johnson & Johnson Pharmaceutical Research & Development...Grünenthal GmbHConcluído
-
Johnson & Johnson Pharmaceutical Research & Development...Grünenthal GmbHConcluídoDor | Dor na região lombar | Osteoartrite, Joelho | Osteoartrite, QuadrilEstados Unidos, Canadá
-
Johnson & Johnson Pharmaceutical Research & Development...Grünenthal GmbHConcluído
-
Johnson & Johnson Pharmaceutical Research & Development...Grünenthal GmbHConcluídoDor | Artralgia | Joanete | Hálux valgoEstados Unidos
-
Johnson & Johnson Pharmaceutical Research & Development...Grünenthal GmbHConcluídoArtralgia | Joanete | Hálux valgo | Avaliação da dor | Tapentadol
-
Johnson & Johnson Pharmaceutical Research & Development...Grünenthal GmbHConcluídoDor | Osteoartrite | Dor lombarEstados Unidos, Austrália, Canadá, Nova Zelândia