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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00385099
Effects Of GW876008 On The Bowel In Patients With Irritable Bowel Syndrome
7 de agosto de 2017 actualizado por: GlaxoSmithKline
A Phase IIa Pharmacodynamic Study of Antagonism of Irritable Bowel Syndrome (IBS) Symptoms by GW876008, a Corticotrophin Releasing Factor 1 Receptor Antagonist (CRF1-RA)
The purpose of this study is to see if GW876008 in Irritable Bowel Syndrome patients will reverse stress-induced hypersensitivity, by looking at thresholds for perception and pain.
Descripción general del estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
10
Fase
- Fase 2
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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London, Reino Unido, NW1 2BU
- GSK Investigational Site
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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
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion criteria:
- Must have irritable bowel syndrome.
Exclusion criteria:
- Subjects who have been taking any medication for the treatment of irritable bowel syndrome within 6 months prior to the start of the study.
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 cruzada
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percent change from Baseline in Laser Doppler regional Rectal Mucosal Blood Flow (RMBF) measured in response to physiological stress (cold water pressor test)
Periodo de tiempo: Baseline (pre-dose) and Study Days 1, 2 and 3
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Laser Doppler flowmetry measures changes in red cell flux using a probe that scans a fixed volume of tissue.
Participants were examined in the left lateral position where DRT4 laser Doppler flow meter was placed against the rectal mucosa 10 centimeter (cm) above the lower limit of the anal margin, and pre-stress readings were taken after a period of 10 minutes of acclimatization in a room with an ambient temperature of 22 degrees Celsius.
Physiological stress was evoked using the cold water pressor test.
Participants were asked to place their hand and forearm into a container of ice-cold water at 0-4degree Celsius and were persuaded to maintain that position for as long as possible during the stress period of 10 minutes.
Readings were then taken during pre-stress and at 5-minute intervals during the stress and recovery periods.
Baseline was defined as the pre-dose assessment.
Change from Baseline was calculated by subtracting the Baseline value minus the post-randomization value.
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Baseline (pre-dose) and Study Days 1, 2 and 3
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Percent Change from Baseline in Laser Doppler regional RMBF measured in response to psychological stress (dichotomous listening test)
Periodo de tiempo: Baseline (pre-dose) and Study Days 1, 2 and 3
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Laser Doppler flowmetry measures changes in red cell flux using a probe that scans a fixed volume of tissue, an indirect measure of flow can be obtained.
Participants were examined in the left lateral position with no prior bowel preparation.
The laser Doppler probe (DRT4 laser Doppler flow meter) was then placed against the rectal mucosa 10 centimeter above the lower limit of the anal margin, and pre-stress readings were taken after a period of 10 minutes of acclimatization in a room with an ambient temperature of 22 degrees Celsius.
The dichotomous listening test was used as a psychological stressor.
At the onset of stress, folk music was played into one ear and rock music into the other ear for 10 minutes.
Readings were then taken during pre-stress and at 5-minute intervals during the stress and recovery periods.
Baseline was defined as the pre-dose assessment.
Change from Baseline was calculated by subtracting the Baseline value minus the post-randomization value.
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Baseline (pre-dose) and Study Days 1, 2 and 3
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of participants with adverse events (AE) and serious adverse events (SAE)
Periodo de tiempo: Up to Week 14
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An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.
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Up to Week 14
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Number of participants with abnormal clinical chemistry data of clinical concern
Periodo de tiempo: Up to Week 14
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The clinical chemistry parameters included albumin, calcium low, creatinine, glucose, magnesium, phosphorus, potassium, sodium, and bicarbonate.
The total number of participants with clinical chemistry data of clinical concern have been presented.
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Up to Week 14
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Number of participants with abnormal hematology data of clinical concern
Periodo de tiempo: Up to Week 14
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The hematology parameters included white blood cell count, neutrophil count, hemoglobin, hematocrit, platelet count and lymphocytes.
The total number of participants with hematology of clinical concern have been presented.
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Up to Week 14
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Participant perceived stress as assessed by a Visual Analogue Scale
Periodo de tiempo: Study Days 1, 2 and 3
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The acute emotional response to stress during each study visit was assessed using a 10 cm description-anchored visual analogue scale, ranging from 0 to 10, where 0=no-stress and 10=Most stressed ever.
Higher scores indicated significant stress.
Participants were asked to mark this before onset of stress, after 10 minutes of stress and finally after 10 minutes of recovery.
After the pre-stress recordings, the period of either physiological or psychological stress were commenced and continued for 10 minutes, followed by a period of recovery for a further 10 minutes.
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Study Days 1, 2 and 3
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Systemic autonomic nervous system response as assessed by systolic blood pressure (SBP) and diastolic blood pressure (SBP)
Periodo de tiempo: Up to Week 14
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As an indicator of change in systemic autonomic activity, blood pressure was measured pre-stress, after 10 minutes of stress and after 10 minutes of recovery using a Dinamap.
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Up to Week 14
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Systemic autonomic nervous system response as assessed by heart rate (HR).
Periodo de tiempo: Up to Week 14
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As an indicator of change in systemic autonomic activity, HR was measured pre-stress, after 10 minutes of stress and after 10 minutes of recovery using a Dinamap.
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Up to Week 14
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Percent change from Baseline in participant reported threshold for pain as a measure to assess Visceral (rectal) electro sensitivity
Periodo de tiempo: Baseline (pre-dose) and Study Days 1, 2 and 3
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Visceral (rectal) sensitivity to pain was measured using previously validated techniques.
In brief, a 1-cm bipolar electrode (21L10) mounted on a 14-gauge Foley catheter was placed initially into the anal canal before the period of acclimatization.
The stimulation parameters were set at 0.5-millisecond pulse width and 10-Hertz frequency for rectal measurements.
The current was then increased slowly and the participants were asked to report when they felt it was painful (pain).
Rectal measurements were made 8 cm above the anal verge.
Measurements were made pre-stress, after 10 minutes of stress, and then after 10 minutes of recovery.
The catheter remained in situ throughout the study but was moved from anal to rectal sites for the 2 measurements.
Baseline was defined as the pre-dose assessment.
Change from Baseline was calculated by subtracting the Baseline value minus the post-randomization value.
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Baseline (pre-dose) and Study Days 1, 2 and 3
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Percent change from Baseline in participant reported threshold for perception of an electrical stimulus as a measure to assess Visceral (rectal) electro sensitivity
Periodo de tiempo: Study Days 1, 2 and 3
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Visceral (rectal) sensitivity to perception was measured using previously validated techniques.
In brief, a 1-cm bipolar electrode (21L10) mounted on a 14-gauge Foley catheter was placed initially into the anal canal before the period of acclimatization.
The stimulation parameters were set at 0.5-millisecond pulse width and 10-Hertz frequency for rectal measurements.
The current was then increased slowly and the participants will be asked to report when they were first aware of this (perception).
Rectal measurements were made 8 centimeter above the anal verge.
Measurements were made pre-stress, after 10 minutes of stress, and then after 10 minutes of recovery.
The catheter remained in situ throughout the study but will be moved from anal to rectal sites for the 2 measurements.
Baseline was defined as the pre-dose assessment.
Change from Baseline was calculated by subtracting the Baseline value minus the post-randomization value.
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Study Days 1, 2 and 3
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Change from Baseline in RMBF at 90 minutes post-dose
Periodo de tiempo: Baseline (pre-dose) and Study Days 1, 2 and 3
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RMBF was measured in response to both physiologic and psychological stress.
Pre-stress readings were taken after 10 minutes of acclimatization.
Readings were taken during pre-stress collections and at 5 minutes intervals during the stress and recovery period.Baseline was defined as the pre-dose assessment.
Change from Baseline was calculated by subtracting the Baseline value minus the post-randomization value.
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Baseline (pre-dose) and Study Days 1, 2 and 3
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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)
8 de diciembre de 2006
Finalización primaria (Actual)
15 de octubre de 2007
Finalización del estudio (Actual)
15 de octubre de 2007
Fechas de registro del estudio
Enviado por primera vez
4 de octubre de 2006
Primero enviado que cumplió con los criterios de control de calidad
4 de octubre de 2006
Publicado por primera vez (Estimar)
6 de octubre de 2006
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de agosto de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
7 de agosto de 2017
Última verificación
1 de agosto de 2017
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CRI103143
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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Gruppo Oncologico del Nord-OvestSeagen Inc.; Servier; Foundation MedicineReclutamientoCáncer de colon en estadio II | Cáncer de colon en estadio III | Cáncer de colon HER2 positivo | Cáncer de colon de tipo salvaje RASItalia
Ensayos clínicos sobre GW876008
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GlaxoSmithKlineTerminadoSíndrome del Intestino Irritable (SII) | Colon IrritableEstados Unidos
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GlaxoSmithKlineTerminadoSujetos sanosEstados Unidos
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GlaxoSmithKlineTerminadoSíndrome del Intestino Irritable (SII)Estados Unidos, Canadá
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GlaxoSmithKlineRetirado
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GlaxoSmithKlineTerminado
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GlaxoSmithKlineTerminadoSujetos sanosEstados Unidos
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GlaxoSmithKlineTerminadoSujetos sanosEstados Unidos
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GlaxoSmithKlineTerminadoFobia socialEstados Unidos, Canadá, Alemania, Suecia, Finlandia, Noruega, Sudáfrica