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- Ensaio Clínico NCT00833794
A Two-Arm Study Comparing the Analgesic Efficacy and Safety of Tramadol HCl Once-a-Day Versus Placebo for the Treatment of Pain Due to Osteoarthritis
25 de abril de 2012 atualizado por: Labopharm Inc.
The purpose of this study is to compare the analgesic efficacy, safety and clinical benefit of Tramadol OAD tablets versus Placebo.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
1028
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 a 80 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria for Open-Label phase:
- Males or females
- Must be between the ages of 40-80
Must meet the American College of Rheumatology (ACR) Clinical Classification Criteria for Osteoarthritis of the Knee:
- Current knee pain
- Less than 30 minutes of morning stiffness with or without crepitus on active motion
- Confirmation either by arthroscopy or radiologist's report (X-rays showing osteophytes, joint space narrowing or subchondral bone sclerosis {eburnation}) within five years prior to entry into the study
- Must have a history of exposure to treatment (for pain due to osteoarthritis (OA) of the knee) with Non-steroidal anti-inflammatory drugs (NSAIDs), COX II inhibitors or tramadol.
- Must be taking one of the above medications on a regular basis in the 30 days prior to Visit 2 (S0).
Must meet the following criteria for severity of pain at Visit 2 (Day S0):
- Have a score of ≥ 4 on the 11-point Numerical Rating Scale (PI-NRS; range: 0-10)
- Have a total increase of ≥ 2 points on the 11-point Numerical Rating Scale (range: 0-10) compared to the rating at Visit 1 (Day SX)
- Must have a erythrocyte sedimentation rate (ESR) < 40 mm/hr
- Must have oral and written language comprehension at a level sufficient to comply with the protocol and complete study-related materials
- Must have signed and dated an approved written Informed Consent form in French, Spanish, English or Romanian, which has also been signed and dated by the Investigator (unless otherwise required by the ethics committee), prior to study participation
Exclusion Criteria for Open-Label phase:
- Has known rheumatoid arthritis or any other rheumatic disease
- Has secondary arthritis i.e. any of the following: septic arthritis; inflammatory joint disease; gout; pseudogout; Paget's disease; target joint fracture; acromegaly; fibromyalgia; Wilson's disease; Ochronosis; Haemochromatosis; Osteochondromatosis; heritable arthritic disorders; or collagen gene mutations
- Has a history of bursitis of the knee (target knee)
- Has a history of pain in the ipsilateral hip (target knee)
- Has had a meniscal tear in the target knee within the last 12 months
- Has had cartilage reconstruction procedure in the target knee
- Has had a therapeutic arthroscopy procedure in the target knee within the last 12 months
- Has a Body Mass Index (BMI) greater than 37
- Has had a major illness, requiring hospitalisation during the 3 months before commencement of the screening period
- Is unwilling to stop taking pain medication other than the study medication (for arthritis or other types of pain) or is unwilling to stop taking other medications for the treatment of OA
- Has previously failed treatment with tramadol or discontinued treatment with tramadol due to adverse events
- Has been taking other opioids (e.g. codeine, oxycodone, hydromorphone, etc.) for treatment of OA or other chronic conditions
- Has received Corticosteroid Injections in the target knee within the last 3 months or Viscous injections in the target knee within the last 6 months
- Has had treatment within the last 3 weeks with any of the following medications: monoamine oxidase inhibitors; tricyclic antidepressants and other tricyclic compounds (e.g. cyclobenzaprine, promethazine); neuroleptics; selective serotonin reuptake inhibitors; serotonin-norepinephrine reuptake inhibitors or any other drug that reduces seizure threshold
- Has had treatment with another investigational agent within the last 30 days
- Has a history of seizure disorder other than Infantile Febrile Seizures
- Has a previous or current opioid dependency
- Has a bowel disease causing malabsorption
- Is pregnant, lactating or of childbearing potential and is unwilling to utilise a medically approved method of contraception during participation in this clinical trial
- Has significant liver disease, defined as active hepatitis or elevated liver enzymes >3 times the upper boundary of the normal range
- Has significant renal disease (defined as creatinine clearance <30 mL/min
- Has a history of current or past substance abuse or dependence, other than nicotine
- Has a known and documented allergy to tramadol or any structurally similar drugs (e.g. opiates)
- Has a known and documented allergy to acetaminophen or any structurally similar drugs
- Has any other condition that, in the opinion of the Investigators, would adversely affect the patient's ability to complete the study or its measures.
Inclusion criteria for the double-blinded phase:
- Patients must continue to meet the open-label eligibility criteria and
- Must have a score of ≥ 4 on the Numerical Rating Scale (NRS) with a total increase of ≥ 2 points on the NRS compared to Visit 3(Day R14) and
- Must not have taken any of the prohibited medications during the Open-label Phase.
Exclusion criteria for the double-blinded phase:
- Patient Request
- Adverse Events that contraindicate further administration of the study medication
- Any other situation where in the opinion of the Investigator continued participation in the study would not be in the patient's best interest.
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 |
---|---|
Comparador de Placebo: 2 Placebo
|
|
Experimental: 1 Tramadol Once A Day
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Pain Intensity Score as Measured by the 11-point Pain Intensity-Numerical Rating Scale Score at the End of the Study (Week 12 or Time of Discontinuation)
Prazo: 12 weeks
|
The Pain Intensity Score is an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain.
The mean score at the end of the study (week 12 or time of discontinuation) was calculated.
|
12 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Pain Intensity Score (11-point PINRS) After 6 Weeks of Maintenance Treatment
Prazo: 6 weeks
|
The Pain Intensity Score is an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain
|
6 weeks
|
Pain Intensity Score Stratified by Dose, at the End of the Study (Week 12 or Time of Discontinuation)
Prazo: 12 weeks
|
Pain Intensity Score (an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain) was stratified by final dose level, at week 12 or time of discontinuation.
The final optimum dose level based upon efficacy and tolerability was kept for the entire study.
The mean score was calculated.
|
12 weeks
|
WOMAC Pain Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)
Prazo: 12 weeks
|
Mean WOMAC Pain Subscale score at week 12.
The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 5-point Likert-scale ranging from no difficulty to extreme difficulty (0-none; 1-slight; 2-moderate; 3-severe; 4-extreme).
The WOMAC pain subscale results from the sum of 5 pain questions.
The maximum total score is 20.
|
12 weeks
|
WOMAC Physical Function Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)
Prazo: 12 weeks
|
Mean WOMAC Physical Function Subscale score at week 12.
The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 5-point Likert-scale ranging from no difficulty to extreme difficulty (0-none; 1-slight; 2-moderate; 3-severe; 4-extreme).
The WOMAC Physical Function subscale results from the sum of 17 physical function questions and the maximum possible score is 68.
|
12 weeks
|
Patient Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)
Prazo: 12 weeks
|
This assessment of overall status integrates the effect of the treatment on pain, side effects, and the patient's expectation of pain relief.
It is made using a 7-point categorical scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse)
|
12 weeks
|
Physician Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)
Prazo: week 12
|
This assessment of overall impression of study drug is made using a 7-point categorical scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse)
|
week 12
|
Time to Response
Prazo: 12 weeks
|
Response was defined as a decrease of ≥1 point in an 11-point PINRS (11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain) from baseline to the last visit.
The time to response was estimated using Kaplan-Meier analysis and a 95% CI for the median time was calculated.
|
12 weeks
|
Discontinuation Due to Lack of Efficacy
Prazo: 12 weeks
|
The number of patients who discontinued due to lack of efficacy was reported.
|
12 weeks
|
Discontinuation Due to Adverse Events
Prazo: 12 weeks
|
The number of patients who discontinued due to adverse events (AEs).
An AE is defined as any untoward medical event that occurs during the course of a clinical investigation in which a patient is administered a pharmaceutical or other therapeutic product.
Its occurrence does not necessarily imply a causal relationship with the treatment.
|
12 weeks
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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Links úteis
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 outubro de 2004
Conclusão Primária (Real)
1 de janeiro de 2006
Conclusão do estudo (Real)
1 de janeiro de 2006
Datas de inscrição no estudo
Enviado pela primeira vez
29 de janeiro de 2009
Enviado pela primeira vez que atendeu aos critérios de CQ
30 de janeiro de 2009
Primeira postagem (Estimativa)
2 de fevereiro de 2009
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
30 de abril de 2012
Última atualização enviada que atendeu aos critérios de controle de qualidade
25 de abril de 2012
Última verificação
1 de abril de 2012
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- MDT3-005
- NCT00833794 (Identificador de registro: ClinicalTrials.gov)
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 .