- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03731364
Study of CA-008 (Vocacapsaicin) in Total Knee Arthroplasty
A Phase 2, Randomized, Double-blind, Placebo-Controlled Efficacy, Pharmacokinetics and Safety Study of CA-008 (Vocacapsaicin) in Subjects Undergoing Total Knee Arthroplasty
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Texas
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Houston, Texas, Estados Unidos, 77402
- HD Research
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Key Inclusion Criteria:
- Plan to undergo an elective primary unilateral total knee arthroplasty (TKA or knee replacement), without collateral procedure or additional surgeries.
- Be a reasonably healthy adult aged 18 - 80 years old, inclusive, with a BMI ≤ 36 kg/m2 and American Society of Anesthesiology (ASA) physical Class 1, 2 or 3 at the time of randomization.
- Males and females must abstain from intercourse, use acceptable birth control methods or be sterile or otherwise incapable of having children.
- Be willing and able to sign the informed consent form (ICF)
- Be willing and able to complete study procedures and pain scales and to communicate meaningfully in English. Be able and willing to return for outpatient follow up visits as required.
Key Exclusion Criteria:
In the opinion of the Investigator,
- have a concurrent painful condition, other than pain in the knee to be replaced, that may require pain treatment during the study period.
- have active skin disease or other clinically significant abnormality at the anticipated site of surgery that could interfere with the planned surgery.
- Have a known allergy to chili peppers, capsaicin or the components of CA-008, ropivacaine, ketorolac, acetaminophen, fentanyl, hydromorphone, morphine or oxycodone.
- Have significant medical, neuropsychiatric or other condition.
The following are considered disallowed medications:
- tolerant to opioids as defined
- capsaicin-containing products or foods.
- central nervous system active agent as an analgesic adjunct medication
- antiarrhythmics except beta-blockers, digoxin, warfarin, lithium, or aminoglycosides or other antibiotics for an infection
- parenteral or oral corticosteroids.
- antianginal, antihypertensive agent or diabetic regimen at a dose that has not been stable for at least 30 days or which is not expected to remain stable while participating in the study.
- Have positive results on the alcohol breath/saliva test indicative of alcohol abuse or urine drug screen indicative of illicit drug use at screening, and/or prior to surgery.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: CA-008 5 mg (0.05 mg/mL) Cohort 1
Cohort 1 (5 mg), was prepared at 0.05 mg/mL CA-008 (vocacapsaicin)
|
5 mg CA-008 (0.05 mg/mL), 10 mg CA-008 (0.1 mg/mL) and 15 mg CA-008 (0.15 mg/mL)
Otros nombres:
|
Comparador de placebos: Placebo - Cohort 1
Placebo for Cohort 1 Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active |
Placebo
|
Comparador activo: CA-008 10 mg (0.1 mg/mL) Cohort 2
Cohort 2 (10 mg), was prepared at 0.1 mg/mL CA-008 (vocacapsaicin)
|
5 mg CA-008 (0.05 mg/mL), 10 mg CA-008 (0.1 mg/mL) and 15 mg CA-008 (0.15 mg/mL)
Otros nombres:
|
Comparador activo: CA-008 15 mg (0.15 mg/mL) Cohort 3
Cohort 3 (15 mg), was prepared at 0.15 mg/mL CA-008 (vocacapsaicin)
|
5 mg CA-008 (0.05 mg/mL), 10 mg CA-008 (0.1 mg/mL) and 15 mg CA-008 (0.15 mg/mL)
Otros nombres:
|
Comparador de placebos: Placebo - Cohorts 2 and 3
Placebo - Cohorts 2 and 3 Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active |
Placebo
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Time-specific Mean Pain Intensity Scores (NRS) at Time 96 Hours for CA-008 vs. Placebo
Periodo de tiempo: At 96 hours
|
Primary Efficacy Endpoint for the Pilot Stage.
Time-specific mean pain intensity scores at Time 96 hours for CA-008 vs. placebo based on a 10-point numerical rating scale (NRS) from 0-10 where 0 is no pain and 10 is the worst pain imaginable).
|
At 96 hours
|
CA-008 Dose vs. Placebo Comparison: Area Under the Curve (AUC) 0 to 96 Hours
Periodo de tiempo: From 0 hours to 96 hours
|
Primary Efficacy Endpoint for Stage 2. Area Under the Curve (AUC) of the NRS current pain intensity scores from Time 0 hours to 96 hours at rest (AUC0 to 96h) where 0 is no pain and 10 is the worst pain imaginable for CA-008 compared to placebo. • During the inpatient stay, NRS at rest beginning with the PACU admission may be assessed once the subject is awake. The maximum is an NRS score of 10 x all 96 hours = 960 NRS units*hrs; the minimum is 0 x 96h = 0 NRS units*hrs |
From 0 hours to 96 hours
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percentage of Subjects Who do Not Require Opioids
Periodo de tiempo: Time 0 hours to Time 96 hours: Opioid Free 0 hours to 96 hours
|
Key Secondary Efficacy Endpoints for Stage 2. For each CA-008 dose vs. placebo comparison, percentage of subjects who do not require opioids.
|
Time 0 hours to Time 96 hours: Opioid Free 0 hours to 96 hours
|
Total Opioid Consumption (in Daily Oral Morphine Equivalents)
Periodo de tiempo: OC from Time 0 hours to Time 96 hours: OC 0 hours to 96 hours
|
Key Secondary Efficacy Endpoints for Stage 2. Mean total postoperative opioid consumption (in daily oral morphine equivalents) for CA-008 compared to placebo
|
OC from Time 0 hours to Time 96 hours: OC 0 hours to 96 hours
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Daneshvari Solanki, MD, First Surgical Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CA-PS-203
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .