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- Ensayo clínico NCT02395653
Safety and Clinical Utility Study of SSEC Fentanyl 40 mcg for Acute Post-op Pain Management in Pediatric Participants
25 de septiembre de 2017 actualizado por: The Medicines Company
An Open Label Evaluation of the Safety and Clinical Utility of the Active, Separated System With Enhanced Controller (SSEC) Fentanyl 40 mcg for the Management of Acute Postoperative Pain in Pediatric Patients 12 to Less Than 18 Years of Age
The objective of this study is to evaluate the safety and clinical utility of the active, SSEC fentanyl 40 micrograms (mcg) for the management of acute, postoperative pain in pediatric participants.
Descripción general del estudio
Descripción detallada
An open label evaluation of the safety and clinical utility of the active, SSEC fentanyl 40 mcg for the management of acute postoperative pain in pediatric participants 12 to less than 18 years of age.
Tipo de estudio
Intervencionista
Inscripción (Actual)
71
Fase
- Fase 3
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
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California
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Palo Alto, California, Estados Unidos, 94304
- Packard Children's Hospital at Stanford
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Florida
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Miami, Florida, Estados Unidos, 33136
- University of Miami/Jackson Memorial Hospital
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Georgia
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Atlanta, Georgia, Estados Unidos, 30342
- Children's Healthcare of Atlanta
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Maryland
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Baltimore, Maryland, Estados Unidos, 21287
- Johns Hopkins Hospital, Charlotte R. Bloomberg Children's Center
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63110
- St. Louis Children's Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- The Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, Estados Unidos, 15224
- Children's Hospital of Pittsburgh of UPMC
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Texas
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Dallas, Texas, Estados Unidos, 75235
- Children's Medical Center of Dallas
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Washington
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Seattle, Washington, Estados Unidos, 98104
- Harborview Medical Center
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Children's Hospital of Wisconsin
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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
12 años a 17 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Participants whose parent(s) or guardian(s) have/has signed and dated an informed consent form for the participant to participate in the study, or participants who have provided written assent to participate in the study
- Male or female inpatients, age 12 to <18 years of age inclusive on the day of surgery
- Participants capable of understanding and cooperating with the requirements of the study, including being able to report their pain intensity using the 11-point Numeric Rating Scale and operate the SSEC
- American Society of Anesthesiologists physical status I, II or III
- Body weight of at least 40.0 kilogram (kg)
- Postoperative participants who have undergone general or regional anesthesia for abdominal, pelvic/genitourinary, orthopedic, or thoracic surgery
- Postoperative participants who have been observed during recovery and are expected to remain hospitalized and have pain requiring parenteral opioids (that is, intravenous [IV] patient-controlled anesthesia) for the next 24 hours or longer
- Participants who are awake and breathing spontaneously with a respiratory rate of 14 to 18 breaths per minute, peripheral capillary oxygen saturation ≥93% (with or without supplemental oxygen), and able to answer questions and follow commands
- Participants who have been observed during recovery, who are awake, able to answer questions and follow commands, and who have been comfortable for at least 30 minutes, with a pain intensity score ≤4 (numeric rating scale 0-10), with or without titration to comfort with IV opioids
Exclusion Criteria:
- Participants who have undergone any surgery on the airway, head, or neck
- Participants who received an extended-release opioid within 48 hours prior to Hour 0 or who are expected to have postoperative analgesia supplied by a continuous regional technique or participant-controlled epidural analgesia
- Participants with a history of allergy or hypersensitivity to fentanyl, skin adhesives, and/or cetylpyridinium chloride
- Participants who are expected to require intensive care or will likely require additional surgical procedures within 36 hours
- Participants who received intra-operative and/or postoperative administration of opioids other than morphine, hydromorphone, fentanyl, sufentanil, or alfentanil. Exception: If there are no medical contraindications, meperidine (pethidine) up to 0.5 milligram/kg IV is permitted during recovery for shivering
- Participants who require airway support (nasal or oropharyngeal airway intubation, or laryngeal mask airway at the time of final baseline assessments (that is, at the time of IONSYS application [Hour 0])
- Participants who are known or suspected to be opioid tolerant, have a history of opioid dependence within 3 months before the start of the study, or who are known to have used illicit drugs or alcohol within 14 days of the start of the study
- Participants with active generalized skin disorders or active local skin disease that precludes SSEC application to the chest or upper arm
- Participants with any coexisting major medical conditions that are likely to interfere with study procedures including, but not limited to, psychiatric conditions, chronic depression, suicidal ideation, autism
- Positive pregnancy test for any female
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: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: SSEC Fentanyl
SSEC fentanyl iontophoretic transdermal system, 40 mcg fentanyl per activation.
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An opioid that has been administered parenterally as an anesthetic and analgesic for more than 20 years.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Assessment Of Participant's Ability To Use The SSEC
Periodo de tiempo: Completed at the time of the participant's termination of study treatment (up to 72 hours after study drug administration)
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Investigator's assessment of participant's ability to use the SSEC system safely and effectively.
The assessment consisted of a 4-level categorical evaluation (poor, fair, good, and excellent).
Because of the descriptive nature of this study, no formal statistical hypothesis testing was performed.
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Completed at the time of the participant's termination of study treatment (up to 72 hours after study drug administration)
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Assessment Of Adherence Of The SSEC System To Skin
Periodo de tiempo: Immediately prior to removal at each 24-hour time point, or at early withdrawal, for up to 3 consecutive days (up to 72 hours)
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The adhesion of each SSEC was evaluated immediately prior to removal at each 24-hour time point, or at early withdrawal.
Adhesion was recorded using the following classification: System adhered to at least 90% of the application area with no edges unattached; System adhered between 75% and 89%; System was <75% adhered and not taped; System was secured with tape.
The number of SSEC systems for all time points in each category is presented.
Because of the descriptive nature of this study, no formal statistical hypothesis testing was performed.
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Immediately prior to removal at each 24-hour time point, or at early withdrawal, for up to 3 consecutive days (up to 72 hours)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change From Baseline To 1 Hour And 24 Hours In Skin Irritation Score After SSEC Removal
Periodo de tiempo: Baseline, 1 hour and 24 hours after SSEC removal.
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Skin irritation at the SSEC application site was to be assessed immediately prior to placement of the study system and at 1 and 24 hours after removal of each study system.
The application site was to be scored using the following scale: 0=No evidence of irritation; 1=Minimal erythema, barely perceptible; 2=Definite erythema, readily visible, minimal edema, or minimal papular response; 3=Erythema and papules; 4=Definite edema; 5=Erythema, edema, and papules; 6=Vesicular eruption; 7=Strong reaction spreading beyond the application site.
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Baseline, 1 hour and 24 hours after SSEC removal.
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Number Of Participants To Experience Clinically Relevant Respiratory Depression (CRRD)
Periodo de tiempo: From the time of application of the first system through 7 days following end of study drug administration.
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Respiratory function and occurrence of CRRD was defined as simultaneous occurrence of bradypnoea (respiratory rate <10 breaths per minute for participants 9-15 years of age and sustained for 1 minute, or <8 breaths per minute for participants 16-17 years of age), with excessive sedation (that is, the participant is not easily aroused).
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From the time of application of the first system through 7 days following end of study drug administration.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Elliot J Krane, MD, Stanford Children's Health
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Hartrick CT, Bourne MH, Gargiulo K, Damaraju CV, Vallow S, Hewitt DJ. Fentanyl iontophoretic transdermal system for acute-pain management after orthopedic surgery: a comparative study with morphine intravenous patient-controlled analgesia. Reg Anesth Pain Med. 2006 Nov-Dec;31(6):546-54. doi: 10.1016/j.rapm.2006.08.011.
- Chelly JE, Grass J, Houseman TW, Minkowitz H, Pue A. The safety and efficacy of a fentanyl patient-controlled transdermal system for acute postoperative analgesia: a multicenter, placebo-controlled trial. Anesth Analg. 2004 Feb;98(2):427-433. doi: 10.1213/01.ANE.0000093314.13848.7E.
- Grond S, Hall J, Spacek A, Hoppenbrouwers M, Richarz U, Bonnet F. Iontophoretic transdermal system using fentanyl compared with patient-controlled intravenous analgesia using morphine for postoperative pain management. Br J Anaesth. 2007 Jun;98(6):806-15. doi: 10.1093/bja/aem102. Erratum In: Br J Anaesth. 2008 Jan;100(1):146.
- Minkowitz HS, Rathmell JP, Vallow S, Gargiulo K, Damaraju CV, Hewitt DJ. Efficacy and safety of the fentanyl iontophoretic transdermal system (ITS) and intravenous patient-controlled analgesia (IV PCA) with morphine for pain management following abdominal or pelvic surgery. Pain Med. 2007 Nov-Dec;8(8):657-68. doi: 10.1111/j.1526-4637.2006.00257.x.
- Minkowitz HS, Yarmush J, Donnell MT, Tonner PH, Damaraju CV, Skowronski RJ. Safety and tolerability of fentanyl iontophoretic transdermal system: findings from a pooled data analysis of four clinical trials. J Opioid Manag. 2010 May-Jun;6(3):203-10. doi: 10.5055/jom.2010.0018.
- Viscusi ER, Reynolds L, Chung F, Atkinson LE, Khanna S. Patient-controlled transdermal fentanyl hydrochloride vs intravenous morphine pump for postoperative pain: a randomized controlled trial. JAMA. 2004 Mar 17;291(11):1333-41. doi: 10.1001/jama.291.11.1333.
- Viscusi ER, Reynolds L, Tait S, Melson T, Atkinson LE. An iontophoretic fentanyl patient-activated analgesic delivery system for postoperative pain: a double-blind, placebo-controlled trial. Anesth Analg. 2006 Jan;102(1):188-94. doi: 10.1213/01.ane.0000183649.58483.77.
- Viscusi ER, Siccardi M, Damaraju CV, Hewitt DJ, Kershaw P. The safety and efficacy of fentanyl iontophoretic transdermal system compared with morphine intravenous patient-controlled analgesia for postoperative pain management: an analysis of pooled data from three randomized, active-controlled clinical studies. Anesth Analg. 2007 Nov;105(5):1428-36, table of contents. doi: 10.1213/01.ane.0000281913.28623.fd.
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)
29 de junio de 2015
Finalización primaria (Actual)
12 de septiembre de 2016
Finalización del estudio (Actual)
12 de septiembre de 2016
Fechas de registro del estudio
Enviado por primera vez
10 de marzo de 2015
Primero enviado que cumplió con los criterios de control de calidad
20 de marzo de 2015
Publicado por primera vez (Estimar)
23 de marzo de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de octubre de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
25 de septiembre de 2017
Última verificación
1 de septiembre de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Complicaciones Postoperatorias
- Dolor
- Manifestaciones neurológicas
- Dolor Postoperatorio
- Efectos fisiológicos de las drogas
- Depresores del sistema nervioso central
- Agentes del sistema nervioso periférico
- Analgésicos
- Agentes del sistema sensorial
- Anestésicos Intravenosos
- Anestésicos Generales
- Anestésicos
- Analgésicos Opiáceos
- Estupefacientes
- Adyuvantes, Anestesia
- Fentanilo
Otros números de identificación del estudio
- PD2013-002
- 2014-002405-37 (Número EudraCT)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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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