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- Ensayo clínico NCT01019928
Esophageal Hypersensitivity Study in Patients With Gastroesophageal Reflux Disease (GERD)
A Phase IIa, Double-blind, Randomized, 2-way Cross-over Study to Evaluate the Effect of a Single Dose of AZD1386 95 mg Compared to Placebo in a Multimodal Experimental Pain Model on Esophageal Sensitivity in GERD Patients With a Partial Response to PPI Treatment
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Provision of signed informed consent form
- BMI 18.5-35.0, inclusive
- Continuous PPI treatment for GERD during the last 4 weeks
Exclusion Criteria:
- Patients that have not experienced any GERD symptoms improvement at all after PPI treatment
- Unstable or clinically significant disorders including cardiovascular, respiratory, renal, hepatic, metabolic, psychiatric, other gastrointestinal and esophageal disorders besides GERD
- Prior surgery of the upper GI tract
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: First AZD1386, then washout, then placebo
|
95 mg, oral solution, single dose
Placebo, oral solution, single dose
|
Experimental: First placebo, then washout, then AZD1386
|
95 mg, oral solution, single dose
Placebo, oral solution, single dose
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 1.5 Hours Post-Dose.
Periodo de tiempo: 1.5 hours post dose
|
A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Heat stimuli were applied by recirculation of heated water in the bag. Prior to recirculation the bag is filled with 7mL to ensure adequate mucosal contact. Water was heated up to a maximum of 63° C and the stimulation was continued until VAS 7 was reached. The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:
|
1.5 hours post dose
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 0.5 Hours Post Dose
Periodo de tiempo: 0.5 hours post dose
|
A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Heat stimuli were applied by recirculation of heated water in the bag. Prior to recirculation the bag is filled with 7mL to ensure adequate mucosal contact. Water was heated up to a maximum of 63° C and the stimulation was continued until VAS 7 was reached. The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:
|
0.5 hours post dose
|
Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 2.5 Hours Post Dose
Periodo de tiempo: 2.5 hours post dose
|
A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Heat stimuli were applied by recirculation of heated water in the bag. Prior to recirculation the bag is filled with 7mL to ensure adequate mucosal contact. Water was heated up to a maximum of 63° C and the stimulation was continued until VAS 7 was reached. The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:
|
2.5 hours post dose
|
Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 0.5 Hours Post Dose
Periodo de tiempo: 0.5 hours post dose
|
A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Volume change in the bag was recorded continuously at each level of the visual analogue scale (VAS) and up to VAS7 (Volume at Visual Analogue Scale 7). The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:
|
0.5 hours post dose
|
Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 1.5 Hours Post-Dose
Periodo de tiempo: 1.5 hours post dose
|
A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Volume change in the bag was recorded continuously at each level of the visual analogue scale (VAS) and up to VAS7 (Volume at Visual Analogue Scale 7). The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:
|
1.5 hours post dose
|
Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 2.5 Hours Post-Dose.
Periodo de tiempo: 2.5 hours post dose
|
A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Volume change in the bag was recorded continuously at each level of the visual analogue scale (VAS) and up to VAS7 (Volume at Visual Analogue Scale 7). The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:
|
2.5 hours post dose
|
Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation 0.5 Hours Post Dose
Periodo de tiempo: 0.5 hours post dose
|
A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES) and stimulations were performed at approximately 8 cm above the LES. The intensity of the stimuli is increased steadily in steps of 0.5 to 1 mA and the intensity corresponding to the VAS levels 1, 3, 5 and 7 were recorded. The current will be increased until the patient report moderate pain (VAS 7) or max 80 mA. The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:
|
0.5 hours post dose
|
Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 1.5 Hours Post Dose
Periodo de tiempo: 1.5 hours post dose
|
A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES) and stimulations were performed at approximately 8 cm above the LES. The intensity of the stimuli is increased steadily in steps of 0.5 to 1 mA and the intensity corresponding to the VAS levels 1, 3, 5 and 7 were recorded. The current will be increased until the patient report moderate pain (VAS 7) or max 80 mA. The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:
|
1.5 hours post dose
|
Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 2.5 Hours Post Dose
Periodo de tiempo: 2.5 hours post dose
|
A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES) and stimulations were performed at approximately 8 cm above the LES. The intensity of the stimuli is increased steadily in steps of 0.5 to 1 mA and the intensity corresponding to the VAS levels 1, 3, 5 and 7 were recorded. The current will be increased until the patient report moderate pain (VAS 7) or max 80 mA. The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:
|
2.5 hours post dose
|
AUCt
Periodo de tiempo: 0 to 4 hours post dose
|
Area under the plasma concentration curve from time zero to the last quantifiable concentration
|
0 to 4 hours post dose
|
Cmax
Periodo de tiempo: 0 to 4 hours post dose
|
Maximum plasma concentration
|
0 to 4 hours post dose
|
Tmax
Periodo de tiempo: 0 to 4 hours post dose
|
Time of maximum plasma concentration
|
0 to 4 hours post dose
|
SBP
Periodo de tiempo: 1.5 hours post dose
|
Supine Systolic Blood Pressure at 1.5 hours post dose
|
1.5 hours post dose
|
DBP
Periodo de tiempo: 1.5 hours post dose
|
Supine Diastolic Blood Pressure at 1.5 hours post dose
|
1.5 hours post dose
|
Pulse
Periodo de tiempo: 1.5 hours post dose
|
Supine Pulse at 1.5 hours post dose
|
1.5 hours post dose
|
QTcF
Periodo de tiempo: 1.5 hours post dose
|
QT interval corrected for heart rate using Fredericia formula(QTcF) at 1.5 hours post dose
|
1.5 hours post dose
|
Body Temperature
Periodo de tiempo: 1.5 hours post dose
|
Oral Body Temperature at 1.5 hours post dose
|
1.5 hours post dose
|
Clinically Relevant Change of Laboratory Variables
Periodo de tiempo: Pre-entry to follow-up
|
Number of participants with clinically relevant change of laboratory variables(clinical chemistry, haematology and urinalysis parameters)
|
Pre-entry to follow-up
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Marie Sundin, AstraZeneca R&D, Mölndal, Sweden
- Investigador principal: Peter Funch-Jensen,, MD, PhD, Aarhus Hospital, Dept of Surgical Gastroenterology, Aarhus, Denmark
Publicaciones y 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 (Estimar)
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
- D9127C00002
- 2008-007420-26
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 Sensitivity in Esophagus
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Meshalkin Research Institute of Pathology of CirculationAún no reclutandolas propiedades de resistencia de la aorta in vivo | las propiedades de resistencia de la aorta in vitro | Modelo de regresión de propiedades de fuerza aórtica in vitro e in vitroFederación Rusa
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Organon and CoTerminado
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Boston Scientific CorporationActivo, no reclutando
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Centre Hospitalier Universitaire de NīmesTerminado
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Kaohsiung Veterans General Hospital.Terminado
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Kaohsiung Veterans General Hospital.TerminadoFertilización in VitroTaiwán
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Adiyaman UniversityTerminado
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Rabin Medical CenterDesconocido
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Istituto Clinico HumanitasTerminado
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Suleyman Demirel UniversityDesconocido
Ensayos clínicos sobre AZD1386
-
AstraZenecaTerminadoDolorBulgaria, Polonia, Hungría, Finlandia, Canadá, Eslovaquia, Japón
-
AstraZenecaTerminadoDolor | Sensibilidad esofágicaSuecia, Dinamarca
-
AstraZenecaTerminadoDolor evocado por capsaicina | Sensibilidad al calor
-
AstraZenecaTerminado