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- Ensayo clínico NCT00684593
A Study to Assess the Clinical Effects of Navarixin in Participants With Psoriasis (MK-7123-009)
17 de enero de 2019 actualizado por: Merck Sharp & Dohme LLC
A Study to Assess the Clinical Effects of SCH 527123 in Psoriasis
This study was conducted: 1) to assess the clinical effect of Navarixin on the Psoriasis Activity and Severity Index (PASI), 2) to determine the effects of Navarixin on the Physician's Global Assessment (PGA), 3) to evaluate the safety and tolerability of Navarixin, and 4) to determine the multiple-dose pharmacokinetics of Navarixin.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
31
Fase
- Fase 2
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 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Body Mass Index (BMI) 19 to 34, BMI = weight (kg)/height (m^2).
- Must have a diagnosis of psoriasis vulgaris (PASI >8) present for at least 1 year. Participants with an on-therapy PASI <=8 at Screening may be considered for inclusion. Participants must be discussed with the Sponsor prior to enrollment and the subject must have indicated that they are not satisfied with current therapy. To be included, participants must have a PASI >8 following washout of their current psoriasis therapy.
- Target lesion selected must be located on the head, trunk, arms or legs and be at least 10 cm^2 in size. The lesion's total numerical ratings for erythema, infiltration, and desquamation must be at least 6 out of the possible 12. Severity score for desquamation must be at least 2.
- Vital sign measurements (taken after ~3 minutes in a supine position) must be within the following ranges: oral body temperature between 35.0°C to 37.5°C; systolic blood pressure, 90 to 160 mm Hg; diastolic blood pressure, 45 to 90 mm Hg; pulse rate, 40 to 100 bpm.
- Have stable disease (ie, off treatment PASI during Screening period and Baseline PASI should not differ by more than 40%).
- Clinical laboratory tests (CBC, blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator/sponsor. Participants must have a neutrophil count of at least 2 x 10^9/L to be included.
- Free of any clinically significant disease (other than psoriasis).
- Willing to give written informed consent and able to adhere to dose and visit schedules.
- For female participants: Negative serum pregnancy test (beta-hCG) and urine pregnancy test. Agree to use medically accepted methods of contraception during and for an appropriate pre-study period while receiving protocol specified medication, and for 1 month after stopping medication. Female participants of non-childbearing potential must be surgically sterilized or be postmenopausal.
- Male subject must agree to use an adequate form of contraception for the duration of the study.
- At Screening, ECG conduction intervals must be within gender specific normal range (ie, QTc for males <430 msec and females <450 msec) or if not within the normal range, the values must be considered clinically insignificant by the investigator and sponsor.
Exclusion Criteria:
- Female participants who are pregnant, intend to become pregnant (within 3 months of ending the study), or are breastfeeding.
- Participants who, in the opinion of the investigator, will not be able to participate optimally in the study.
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug.
- History of any infectious disease within 4 weeks prior to drug administration and/or are positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV).
- Immunocompromised participants.
- Positive screen for drugs with a high potential for abuse or have a history of drug or alcohol abuse in the past 2 years.
- History of mental instability or who have been treated for mood disorders.
- Donated blood in the past 60 days.
- Previous treatment with study medication.
- Currently participating in another clinical study or have participated in a clinical study within 30 days.
- Part of the study staff personnel or family members of the study staff personnel.
- Demonstrated clinically significant (requiring intervention) allergic reactions or who are known to be allergic to components of local anesthetics.
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: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Navarixin
Navarixin 30 mg administered orally once daily for 28 days.
|
Navarixin capsules orally, once daily for 28 days.
|
Comparador de placebos: Placebo
Matching placebo to Navarixin administered orally once daily for 28 days.
|
Matching placebo capsules to Navarixin orally, once daily for 28 days.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Mean Percent Change From Baseline in the Psoriasis and Activity Severity Index (PASI) Score at Day 29
Periodo de tiempo: Baseline and Day 29
|
PASI score is a means to qualify the extent and severity of psoriatic lesions.
The total score is calculated as the sum of the extent and severity of lesions on the head, arms, trunk, and legs and the score can range from 0 (no symptoms) to 72 (maximum symptoms).
|
Baseline and Day 29
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Participants by Physician's Assessment of Global Improvement (PGA) Score At Day 29
Periodo de tiempo: Day 29
|
The PGA is a questionnaire that asks the treating physician to rate the participant's signs and symptoms on a scale where 0=worse, 1=unchanged, 2= slight improvement, 3= fair improvement, 4= good improvement, 5= excellent improvement, and 6=cleared, with higher scores indicating better outcomes.
|
Day 29
|
Mean Maximum Plasma Concentration (Cmax) of Navarixin at Day 28
Periodo de tiempo: Day 28
|
Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours following oral administration of Navarixin to determine the mean Cmax at Day 28.
Blood samples were not collected from the placebo group to evaluate this endpoint.
|
Day 28
|
Mean Area Under the Plasma Concentration-Time Curve From Time 0-24 Hours (AUC [0-24]) of Navarixin at Day 28
Periodo de tiempo: Day 28
|
Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours following oral administration of Navarixin to determine the mean AUC(0-24) at Day 28.
Blood samples were not collected from the placebo group to evaluate this endpoint.
|
Day 28
|
Mean Terminal Phase Half-life (T1/2) of Navarixin at Day 28
Periodo de tiempo: Day 28
|
Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours to determine the mean T1/2 of Navarixin following oral administration at Day 28.
Blood samples were not collected from the placebo group to evaluate this endpoint.
|
Day 28
|
Median Time to Maximum Plasma Concentration (Tmax) of Navarixin at Day 28
Periodo de tiempo: Day 28
|
Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours following oral administration of Navarixin to determine the Mean Tmax at Day 28.
Blood samples were not collected from the placebo group to evaluate this endpoint.
|
Day 28
|
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 (Actual)
1 de junio de 2007
Finalización primaria (Actual)
1 de octubre de 2007
Finalización del estudio (Actual)
1 de octubre de 2007
Fechas de registro del estudio
Enviado por primera vez
22 de mayo de 2008
Primero enviado que cumplió con los criterios de control de calidad
22 de mayo de 2008
Publicado por primera vez (Estimar)
26 de mayo de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de febrero de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
17 de enero de 2019
Última verificación
1 de enero de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- P04481 (Otro identificador: Merck Protocol Number)
- 2006-006601-83 (Número EudraCT)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Sí
Descripción del plan IPD
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Datos del estudio/Documentos
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. .
Ensayos clínicos sobre Soriasis
-
ProgenaBiomeReclutamientoSoriasis | Psoriasis vulgar | Psoriasis del cuero cabelludo | Placa psoriásica | Psoriasis universal | Rostro de psoriasis | Clavo de la psoriasis | Psoriasis difusa | Psoriasis Punctata | Psoriasis palmar | Psoriasis circinata | Psoriasis anular | Psoriasis genital | Psoriasis GeográficaEstados Unidos
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Centre of Evidence of the French Society of DermatologyReclutamientoSoriasis | Psoriasis vulgar | Psoriasis del cuero cabelludo | Placa psoriásica | Psoriasis universal | Psoriasis palmar | Eritrodermia psoriásica | Uña psoriásica | Psoriasis en gotas | Psoriasis inversa | Psoriasis pustulosaFrancia
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Clin4allReclutamientoPsoriasis del cuero cabelludo | Clavo de la psoriasis | Psoriasis palmar | Psoriasis genital | Psoriasis plantarFrancia
-
Herlev and Gentofte HospitalReclutamientoInfarto de miocardio | Isquemia miocardica | Enfermedades cardíacas | Enfermedades cardiovasculares | Insuficiencia cardiaca | Carrera | Soriasis | Insuficiencia Cardíaca Diastólica | Psoriasis vulgar | Factor de riesgo cardiovascular | Insuficiencia Cardíaca Sistólica | Disfunción Ventricular Izquierda | Psoriasis... y otras condicionesDinamarca
-
UCB Biopharma S.P.R.L.TerminadoPsoriasis moderada a severa | Psoriasis Pustular Generalizada y Psoriasis EritrodérmicaJapón
-
Innovaderm Research Inc.TerminadoPsoriasis del cuero cabelludo | Psoriasis pustulosa palmo-plantar | Psoriasis palmoplantar no pustulosa | Psoriasis de codo | Psoriasis de la parte inferior de la piernaCanadá
-
AmgenTerminadoPsoriasis tipo psoriasis | Psoriasis tipo placaEstados Unidos
-
TakedaReclutamientoPsoriasis pustulosa generalizada | Psoriasis eritrodérmicaJapón
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Assiut UniversityDesconocidoPacientes con psoriasis
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Shanghai Huaota Biopharmaceutical Co., Ltd.ReclutamientoPsoriasis pustulosa generalizada (PPG)Porcelana
Ensayos clínicos sobre Navarixin 10 mg
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AstraZenecaTerminadoSíndrome de Zollinger-Ellison | Esofagitis por reflujo (RE) | Úlcera gástrica (GU) | Úlcera Duodenal (DU) | Úlcera anastomótica (AU) | Enfermedad de esofagitis por reflujo no erosiva (NERD)Japón
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Dong-A ST Co., Ltd.TerminadoSaludableCorea, república de
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The Netherlands Cancer InstituteTerminado
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Merck Sharp & Dohme LLCTerminado
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Vedic Lifesciences Pvt. Ltd.Aún no reclutandoInfecciones del Tracto Respiratorio SuperiorIndia
-
Impact Therapeutics, Inc.Aún no reclutando
-
Idorsia Pharmaceuticals Ltd.Terminado
-
South China Center For Innovative PharmaceuticalsXiangya Hospital of Central South UniversityTerminado
-
Merck Sharp & Dohme LLCTerminado
-
Impact Therapeutics, Inc.Aún no reclutando