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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02081703
Study to Evaluate Safety/Efficacy of a Single Pre-Op Dose of AYX1 Injection to Treat Pain After Knee Replacement Surgery
14 de julho de 2015 atualizado por: Adynxx, Inc.
A Phase 2 Study to Evaluate the Safety & Efficacy of Two Dose/Volume Levels of a Single Intrathecal Preoperative Administration of AYX1 Injection in Patients Undergoing Unilateral Total Knee Arthroplasty
The objectives of this study are to evaluate the safety and analgesic efficacy of a single preoperative intrathecal administration of AYX1 Injection at two dose/volume levels.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Intervencional
Inscrição (Real)
120
Estágio
- Fase 2
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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Alabama
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Sheffield, Alabama, Estados Unidos
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Arizona
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Phoenix, Arizona, Estados Unidos
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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
40 anos a 80 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Scheduled to undergo primary unilateral TKA for painful osteoarthritis without congenital knee pathology
- American Society of Anesthesiologists Physical Status Classification System ≤ 3
- Medically stable as determined by the Investigator based on pre-study medical history, physical/neurological examination, clinical laboratory tests, and 12-lead electrocardiogram (ECG) findings
- Body Mass Index of 18-40 kg/m2
- Stable medical regimen for at least 1 month before randomization
- Able to read and understand study instructions in English, and willing and able to comply with all study procedures
Exclusion Criteria:
- More than 2 other current focal areas of pain, none greater in intensity than the target knee and no other active chronic pain conditions that would compromise operative knee pain evaluation
- Inflammatory arthridities (e.g., rheumatoid arthritis, lupus, ankylosing spondylitis, psoriatic arthritis), with the exception of clinically stable/non-active gout that does not affect the knee and does not interfere with walking
- Operative arthroscopy in the surgical knee in the last 4 months (except for meniscal repair which will be no shorter than 6 months before randomization) or in the contralateral knee in the last 2 months (or 3 months for meniscal repair), or other prior surgery in either knee in the last 12 months, except for diagnostic arthroscopy
- Planned use of any of the following for TKA: general anesthesia using potent inhalational agents, peripheral nerve block (i.e., femoral nerve block), neuroaxial (intrathecal or epidural) opioids postoperatively, or knee capsule injections
- Received aspirin or any nonsteroidal anti-inflammatory drug (NSAID) prior to randomization within the washout period required by the surgical team for surgery with spinal anesthetic, or planned use of NSAIDS post-operatively through Day 28
- Use of more than 20 mg per day (on average) of oral morphine or its equivalent within 1 month prior to randomization
- Use of adjuvant analgesics for chronic pain control (e.g., gabapentin, pregabalin) within 2 weeks prior to randomization or planned use post-operatively through Day 28
- Daily use of benzodiazepines in the 3 months prior to randomization (unless used for sleep and dosage will be consistent after surgery)
- Use of systemic corticosteroids (does not include inhaled steroids) within 3 months or intra-articular steroid injections within 1 month prior to randomization, or planned use of either post-operatively through Day 28
- Treatment with immunosuppressives, antipsychotics, anticholinergics, or anticonvulsants within 1 month of randomization, with the exception of aspirin for cardiac prophylaxis (as long as discontinued within 1 week of randomization)
- Current neurologic disorder, which could confound the assessment of pain (e.g., Parkinson's, Multiple Sclerosis)
- Current active depression symptoms
- Has had a change in dose or regimen of SSRIs or SNRIs for depression within 1 month of randomization
- Mini Mental State Exam score < 24 at Screening
- Severe pulmonary disease; if symptomatic sleep apnea is currently treated with continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BIPAP), use must be continued postoperatively at least during the inpatient period. Patients with sleep apnea associated with a history of postoperative delirium are excluded.
- Current evidence of alcohol abuse or history of alcohol-related complications within 1 year of randomization including, but not limited to, alcoholic withdrawal seizures, hallucinations, delirium tremens or detoxification treatment
- Known or suspected history of illicit drug abuse within 1 year before randomization, current or planned use of medical marijuana, or history of opioid dependence within 2 years before randomization
- Any malignancy within the past year, with the exception of basal cell carcinoma or uncomplicated or stable skin cancers documented to not require further or immediate treatment
- Women who are pregnant or nursing
- Previous participation in any study involving AYX1 Injection
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: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: AYX1 Injection 660 mg / 6 mL
Single Intrathecal (spinal) administration of AYX1 Injection (660 mg in 6 mL) just prior to intrathecal administration of spinal anesthetic for knee surgery
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6 mL solution for intrathecal injection with 660 mg of AYX1
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Comparador de Placebo: Placebo Injection 6 mL
Single Intrathecal (spinal) administration of Placebo Injection (6 mL) just prior to intrathecal administration of spinal anesthetic for knee surgery
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6 mL solution for intrathecal injection; Vehicle formulation designed to mimic AYX1 Injection (with no active drug)
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Experimental: AYX1 Injection 1100 mg / 10 mL
Single Intrathecal (spinal) administration of AYX1 Injection (1100 mg in 10 mL) just prior to intrathecal administration of spinal anesthetic for knee surgery
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10 mL solution for intrathecal injection with 1100 mg of AYX1
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Comparador de Placebo: Placebo Injection 10 mL
Single Intrathecal (spinal) administration of Placebo Injection (10 mL) just prior to intrathecal administration of spinal anesthetic for knee surgery
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10 mL solution for intrathecal injection; Vehicle formulation designed to mimic AYX1 Injection (with no active drug)
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Pain with walking during 5 meter walk test
Prazo: 0-48 hours after surgery
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Mean pain rating on the Numerical Rating Scale (NRS) with walking during the 5 meter walk test during the inpatient stay (0-48 hours)
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0-48 hours after surgery
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Pain with walking during 15 meter walk test
Prazo: Hospital Discharge to Day 28
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Mean pain rating on the Numerical Rating Scale (NRS) with walking during the 15 meter walk test during the outpatient period up to Day 28
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Hospital Discharge to Day 28
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Pain with 45 degrees of knee flexion
Prazo: 0-48 hours after surgery
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Mean pain rating on the Numerical Rating Scale (NRS) for 45 degrees passive knee flexion during the inpatient stay
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0-48 hours after surgery
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Pain with 90 degrees of knee flexion
Prazo: Hospital discharge to Day 28
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Mean pain rating on the Numerical Rating Scale (NRS) for 90 degrees passive knee flexion during the outpatient period to Day 28
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Hospital discharge to Day 28
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Total use of opioid medications (morphine equivalents) during hospital stay
Prazo: 0-48 hours after surgery
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0-48 hours after surgery
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Total use of opioid medications (morphine equivalents) post-discharge to Day 28
Prazo: Hospital Discharge to Day 28
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Hospital Discharge to Day 28
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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Percentage of subjects achieving 90 degrees of knee flexion
Prazo: Hospital discharge to Day 42
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Percentage of subjects achieving 90 degrees of active knee flexion in the operative knee at Discharge through Day 42
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Hospital discharge to Day 42
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Donald C Manning, MD, PhD, Adynxx, Inc.
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 maio de 2014
Conclusão Primária (Real)
1 de junho de 2015
Conclusão do estudo (Real)
1 de junho de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
5 de março de 2014
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de março de 2014
Primeira postagem (Estimativa)
7 de março de 2014
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
4 de agosto de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
14 de julho de 2015
Última verificação
1 de julho de 2015
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ADYX-003
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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