- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02084511
Effectiveness and Safety of Different Doses of BI 1026706 in Patients With Postoperative Dental Pain
Effectiveness and Safety of Different Doses of BI 1026706 in Patients With Postoperative Dental Pain (a Single-centre, Partially Double-blinded, Randomised, placebo-and Active Comparator-controlled, Single-dose, Parallel-group Study)
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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Verona, Italia
- 1320.13.39001 Boehringer Ingelheim Investigational Site
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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:
- Healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (Blood Pressure,Pulse Rate), 12-lead electrocardiogram, and clinical laboratory tests
- Age 18 to 55 years (incl.)
- Body Mass Index 18.5 to 29.9 kg/m2 (incl.)
- Patients scheduled for removal of one mandibular third molar with partial or complete bony impaction. If medically indicated, the ipsilateral third molar in the upper jaw could also be removed;
- Surgery will be conducted under local anaesthesia using 12% lidocaine (with epinephrine). Intravenous sedations and general anaesthetics are not permitted.
- Reliable, cooperative, and of adequate intelligence to record the requested information on the analgesic questionnaire form
- Examined by the attending oral surgeon or physician and medically cleared to participate in the study
- Scheduled to undergo a qualifying surgical procedure
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
Exclusion criteria:
- Any finding in the medical examination (including Blod Pressure, Pulse Rate or electrocardiogram) deviating from normal and judged clinically relevant by the investigator
- Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease judged clinically relevant by the investigator
- Acute local infection at the time of surgery that could confound the post-surgical evaluation
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s)
Plan de estudios
¿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: BI 1026706 low dose
|
Placebo to BI 1026706 solution
BI 1026706
Placebo to BI 1026706 tablet
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Experimental: BI 1026706 high dose
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BI 1026706
Placebo to BI 1026706 tablet
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Experimental: Placebo reference
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Placebo to BI 1026706 solution
Placebo to BI 1026706 tablet
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Experimental: Celecoxib reference
Celecoxib capsule
|
Placebo to BI 1026706 solution
Celecoxib capsule
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
SPID0-8h
Periodo de tiempo: up to 8 hours post drug administration
|
Time-weighted sum of pain intensity difference (PID) from 0 to 8 hours post drug administration (SPID0-8h).
SPID0-8h: possible range (-400; 800).
The greater SPID0-8 the greater the reduction of pain intensity over the first 8 hours post drug administration.
|
up to 8 hours post drug administration
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
TOTPAR0-8h
Periodo de tiempo: up to 8 hours post drug administration
|
Time-weighted total pain relief (PAR) from 0 to 8 hours (TOTPAR0-8h).
(TOTPAR0-8h)TOTPAR0-8h: possible range (0;32).
The greater TOTPAR0-8h the more pain relief was experienced over the first 8 hours post drug administration.
|
up to 8 hours post drug administration
|
|
SPID0-2h
Periodo de tiempo: up to 2 hours post drug administration
|
Time-weighted sum of PID from 0 to 2 hours (SPID0-2h).
SPID0-2h: possible range (-100; 200).
The greater SPID0-2 the greater the reduction of pain intensity over the first 2 hours post drug administration.
|
up to 2 hours post drug administration
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|
Time to Meaningful Pain Relief
Periodo de tiempo: up to 10 hours post drug administration
|
Time to meaningful pain relief was captured by a stopwatch started by the trial staff immediately after administration of study medication and stopped by the subject as soon as a meaningful pain relief was felt by the subject. If a subject did not have any meaningful pain relief up to 10 h, the time was censored at 10 h. Kaplan-Meier estimates over time for each treatment and time to event endpoint 'Time to meaningful pain relief' were presented descriptively. |
up to 10 hours post drug administration
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Time to First Dose of Rescue Medication
Periodo de tiempo: up to 10 hours post drug administration
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The time to first dose of rescue medication was defined by the difference in time of the study drug intake and the time of first rescue medication use within the first 10 h after study drug administration. Kaplan-Meier estimates over time for each treatment and time to event endpoint 'Time to first dose of rescue medication' were presented descriptively. Subjects without intake of rescue medication within the first 10 hours after study drug administration were censored at 10 hours. |
up to 10 hours post drug administration
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|
Percentage of Patients With Drug-related Adverse Events
Periodo de tiempo: From first drug administration until 3 days after last drug administration, upto 4 days
|
Percentage of patients with drug-related adverse events
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From first drug administration until 3 days after last drug administration, upto 4 days
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Colaboradores e Investigadores
Patrocinador
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
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Complicaciones Postoperatorias
- Dolor
- Manifestaciones neurológicas
- Dolor Postoperatorio
- 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
- Inhibidores de la ciclooxigenasa 2
- Celecoxib
Otros números de identificación del estudio
- 1320.13
- 2013-003580-62 (Número EudraCT: EudraCT)
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