- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01343303
A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-39439335 in Patients With Osteoarthritis
8 de agosto de 2012 actualizado por: Janssen Research & Development, LLC
A Double-Blind, Randomized, Placebo-and Active-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-39439335 in Subjects With Osteoarthritis
The purpose of this study is to evaluate the safety of multiple oral doses of JNJ-39439335 and to assess how JNJ-39439335 is absorbed (taken in), distributed, metabolized (broken down), and eliminated from the body (referred to as pharmacokinetics) in osteoarthritis patients.
This study will also assess the effectiveness of JNJ-39439335 on pain.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This will be a double-blind (patient and study staff will not know the identity of assigned treatment), randomized (assignment to 1 to 3 treatment groups will be by chance, like "flipping a coin"), placebo-controlled, multiple dose study conducted at up to two clinical sites.
Up to 42 patients with osteoarthritis of the knee will be enrolled in 3 cohorts (Cohort 1 to 3).
Additional cohorts (up to 14 patients per cohort) may be added after completion of Cohort 3. The study consists of eligibility screening, a treatment phase, and 4 follow-up visits.
The study duration for each patient will be approximately 10 weeks.
Patients safety will be closely monitored during the study by review of adverse events, electrocardiograms, vital signs (including oral temperature), clinical laboratory tests, and physical examinations.
During specified study visits, blood samples will be collected for pharmacokinetics, pharmacodynamics (inpatient patients), and pharmacogenomic (optional) evaluations of JNJ-39439335.
The effectiveness of JNJ-39439335 will be evaluated by assessing pain using an 11-point numerical rating scale and by the Western Ontario and McMaster Osteoarthritis Index.
In Cohort 1 and 2, all patients will take their study medication orally, twice a day for 21 days.
The treatment groups for Cohort 1 are JNJ-39439335 10 mg, naproxen 500 mg every 12 hours, and placebo.
The treatment groups for Cohort 2 are JNJ-39439335 25 mg, naproxen 500 mg every 12 hours, and placebo.
The treatment groups for Cohort 3 will be determined based on the results of Cohort 1 and 2.
Tipo de estudio
Intervencionista
Inscripción (Actual)
43
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
-
George, Sudáfrica
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Nonsmoker >= 6 months prior to first dose
- body mass index (BMI) <= 36 kg/m2
- Meet American College of Rheumatology (ACR) clinical classification criteria for osteoarthritis of knee by meeting at least 3 of the following: age > 50, morning stiffness < 30 minutes, crepitus on active motion, bony tenderness, bony enlargement, no palpable warmth of synovium
- Has Functional Class I-III osteoarthritis (OA) of knee with continuing OA-knee joint pain >= 5 days/week x 3 months prior to screening, and has been taking a non-opioid analgesic for OA knee pain daily for >=5 days prior to screening with benefit
- Otherwise healthy based on physical exam, medical history, vital signs, 12-lead electrocardiogram (ECG), can clinical laboratory tests
- Women must be postmenopausal or surgically sterile.
Exclusion Criteria:
- Oral temperature >37.5 deg C at Screening or Day -1
- Failure of burn prevention measures quiz at Screening
- patients with occupations or hobbies in which they are routinely exposed to situations in which they could sustain burns
- orthopedic and/or prosthetic device on target knee joint
- Significant pain outside the target knee, including significant hip or back pain (bilateral knee OA is permitted)
- Unable to discontinue prior analgesic medications/non-steroidal antiinflammatory drugs (NSAIDS) other than paracetamol during the study
- Surgical intervention for any pain within 3 months prior to screening or has plans for surgical intervention while in the study
- History of prior diagnosis of inflammatory arthritis (including rheumatoid arthritis)
- Treatment with local corticosteroid injections or viscosupplementation in target joint, or use of oral or intramuscular corticosteroids, within 3 months prior to Screening
- History of active peptic ulceration, active dyspepsia, gastrointestinal bleeding, Crohn's disease, ulcerative colitis, chronic diarrhea esophageal, and gastric or duodenal ulcer within 3 months prior to screening or any other condition, which in the Investigator's opinion, precludes use of an NSAID.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 001
JNJ-39439335 2 x 5 mg tablets once daily for 21 days
|
2 x 25 mg tablets once daily for 21 days
2 x 5 mg tablets once daily for 21 days
|
|
Experimental: 002
JNJ-39439335 2 x 25 mg tablets once daily for 21 days
|
2 x 25 mg tablets once daily for 21 days
2 x 5 mg tablets once daily for 21 days
|
|
Otro: 003
Naproxen 500 mg capsule every 12 hours for 21 days
|
500 mg capsule every 12 hours for 21 days
|
|
Comparador de placebos: 004
Placebo Placebo tablet/capsule every 12 hours for 21 days
|
Placebo tablet/capsule every 12 hours for 21 days
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Number of participants with adverse events as a measure of safety and tolerability
Periodo de tiempo: From screening up to final follow up visit.
|
From screening up to final follow up visit.
|
|
Change from baseline in vital signs, including oral body temperature
Periodo de tiempo: From Day -1 up to final follow up visit
|
From Day -1 up to final follow up visit
|
|
Change from baseline in ECG
Periodo de tiempo: From Day -1 up to final follow up visit
|
From Day -1 up to final follow up visit
|
|
Change from baseline in clinical laboratory tests
Periodo de tiempo: From Day -1 up to final follow up visit
|
From Day -1 up to final follow up visit
|
|
Concentaton of JNJ-39439335 in blood and urine samples
Periodo de tiempo: From Day 1 up to final follow up visit
|
From Day 1 up to final follow up visit
|
|
Concentration of JNJ-39439335 in blood and urine samples
Periodo de tiempo: From Day 1 up to final follow up visit
|
From Day 1 up to final follow up visit
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Change from baseline in pain numerical rating scale
Periodo de tiempo: From Day 2 up to final follow up visit
|
From Day 2 up to final follow up visit
|
|
Change from baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC)
Periodo de tiempo: From Day -1 up to final follow up visit
|
From Day -1 up to final follow up visit
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de marzo de 2011
Finalización del estudio (Actual)
1 de diciembre de 2011
Fechas de registro del estudio
Enviado por primera vez
7 de abril de 2011
Primero enviado que cumplió con los criterios de control de calidad
26 de abril de 2011
Publicado por primera vez (Estimar)
28 de abril de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
9 de agosto de 2012
Última actualización enviada que cumplió con los criterios de control de calidad
8 de agosto de 2012
Última verificación
1 de agosto de 2012
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Articulares
- Enfermedades musculoesqueléticas
- Enfermedades reumáticas
- Artritis
- Osteoartritis
- Artrosis, Rodilla
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes del sistema nervioso periférico
- Inhibidores de enzimas
- Analgésicos
- Agentes del sistema sensorial
- Agentes antiinflamatorios no esteroideos
- Analgésicos no narcóticos
- Agentes antiinflamatorios
- Agentes antirreumáticos
- Inhibidores de la ciclooxigenasa
- Supresores de gota
- Naproxeno
Otros números de identificación del estudio
- CR018292
- 39439335EDI1014 (Otro identificador: Janssen Research & Development, LLC)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .