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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00528931
A Pharmacokinetic Study of AA4500 (XIAFLEX™, Proposed Name) in Subjects With Dupuytren's Contracture
A Phase 1, Open-Label Study to Assess the Pharmacokinetics and Safety of a Single Injection of AA4500 0.58 mg in Subjects With Dupuytren's Contracture
A Phase 1, open-label, single-dose pharmacokinetic study in subjects with Dupuytren's contracture conducted at one site in the United States. All subjects received a single dose of AA4500 0.58 mg, which was injected directly into the cord affecting either the metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint. Pharmacokinetic blood samples were collected before dosing, at predetermined time points through the 24 hours after dosing, Day 7, and Day 30. Efficacy and safety assessments were performed up to 30 days after the AA4500 0.58 injection.
This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 [NCT00528606]and AUX-CC-859 [NCT00533273]) and 7 non-pivotal studies were evaluated.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Burbank, California, Estados Unidos, 91505
- Providence Clinical Research
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Subjects with a diagnosis of Dupuytren's contracture, with a fixed flexion deformity of at least one finger, other than the thumb, that had a contracture at least 20°, but not greater than 100° for MP (80° for PIP) joints, caused by a palpable cord.
- Had a positive "table top test," defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
- Were naive to AA4500 treatment.
- Were judged to be in good health.
Exclusion Criteria:
- Had a chronic muscular, neurological, or neuromuscular disorder that affected the hands.
- Had received treatment for Dupuytren's contracture within 90 days of the AA4500 injection to the MP or PIP selected, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon on the selected primary joint within 90 days before the first dose of study drug.
- Had a known recent history of stroke, bleeding, a disease process that affected the hands, or other medical condition, which in the investigator's opinion, would make the subject unsuitable for enrollment in the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: AA4500 0,58 mg
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Single dose of AA4500 0.58 mg into the cord
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Subjects With AUX I and AUX II Detected in Their Blood After a Single Dose of AA4500
Periodo de tiempo: Before dosing, at predetermined time points through the 24 hours after dosing, Day 7, and Day 30
|
AUX I and AUX II are the constituent protein collagenases of collagenase clostridium histolyticum (AA4500).
Plasma concentrations of AUX I and AUX II were assessed through an enzymye-linked-immunoabsorbent assay (ELISA).
|
Before dosing, at predetermined time points through the 24 hours after dosing, Day 7, and Day 30
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Clinical Success
Periodo de tiempo: 30 days after treatment to the primary joint
|
Clinical success defined as a reduction in contracture (ie, flexion deformity) to ≤5° of normal as measured by finger goniometry 30 days after an injection.
Last observation carried forward (LOCF) after the injection was used if the status at day 30 could not be determined.
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30 days after treatment to the primary joint
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Clinical Improvement
Periodo de tiempo: 30 days after treatment to the primary joint
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Clinical improvement defined as ≥50% reduction from baseline in contracture within 30 days of the injection.
LOCF after the injection was used if the status at day 30 could not be determined.
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30 days after treatment to the primary joint
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Percent Change From Baseline Contracture
Periodo de tiempo: Baseline, 30 days after treatment to the primary joint
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Change from baseline in the degree of fixed-flexion contracture calculated as 100 times (baseline contracture minus last available post-injection contracture measurement) divided by baseline contracture where a positive change indicates a reduction in the degree of contracture.
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Baseline, 30 days after treatment to the primary joint
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Change From Baseline Range of Motion
Periodo de tiempo: Baseline, 30 days after treatment to the primary joint
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Range of motion defined as the difference between the finger extension angle and finger flexion angle expressed in degrees
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Baseline, 30 days after treatment to the primary joint
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Veronica Urdaneta, MD, Endo Pharmaceuticals
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
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
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias De Tejidos Conectivos Y Blandos
- Neoplasias por tipo histológico
- Neoplasias
- Enfermedades Articulares
- Enfermedades musculoesqueléticas
- Enfermedades del tejido conectivo
- Enfermedades Musculares
- Neoplasias Del Tejido Conectivo
- Neoplasias De Tejido Fibroso
- Fibroma
- Contractura
- Contractura de Dupuytren
Otros números de identificación del estudio
- AUX-CC-855
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. .
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