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- Ensaio Clínico NCT00385099
Effects Of GW876008 On The Bowel In Patients With Irritable Bowel Syndrome
7 de agosto de 2017 atualizado 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.
Visão geral do estudo
Tipo de estudo
Intervencional
Inscrição (Real)
10
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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London, Reino Unido, NW1 2BU
- GSK Investigational Site
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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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)
Prazo: 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)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Number of participants with adverse events (AE) and serious adverse events (SAE)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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).
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
8 de dezembro de 2006
Conclusão Primária (Real)
15 de outubro de 2007
Conclusão do estudo (Real)
15 de outubro de 2007
Datas de inscrição no estudo
Enviado pela primeira vez
4 de outubro de 2006
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de outubro de 2006
Primeira postagem (Estimativa)
6 de outubro de 2006
Atualizações de registro de estudo
Última Atualização Postada (Real)
8 de agosto de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de agosto de 2017
Última verificação
1 de agosto de 2017
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CRI103143
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Cólon irritável
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Nihon Pharmaceutical Co., LtdConcluídoCâncer de intestino | Adenoma Gástrico | Colon Nos Polipectomia Adenoma TubularJapão
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Istituto Clinico HumanitasNuovo Regina Margherita HospitalDesconhecidoCâncer colorretal | Colon Nos Polipectomia Adenoma Tubular | Adenomas serrilhadosItália
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Istituto Clinico HumanitasSan Gerardo Hospital; Azienda Ospedaliero Universitaria Maggiore della CaritaConcluídoSangramento | Pólipos colônicos | Complicações | Pólipo do Intestino Grosso | Colon Nos Polipectomia Adenoma TubularItália
Ensaios clínicos em GW876008
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GlaxoSmithKlineConcluídoSíndrome do Intestino Irritável (SII) | Cólon irritávelEstados Unidos
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GlaxoSmithKlineConcluídoSujeitos SaudáveisEstados Unidos
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GlaxoSmithKlineConcluídoSíndrome do Intestino Irritável (SII)Estados Unidos, Canadá
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GlaxoSmithKlineRetirado
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GlaxoSmithKlineConcluído
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GlaxoSmithKlineConcluídoSujeitos SaudáveisEstados Unidos
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GlaxoSmithKlineConcluídoFobia socialEstados Unidos, Canadá, Alemanha, Suécia, Finlândia, Noruega, África do Sul
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GlaxoSmithKlineConcluídoSujeitos SaudáveisEstados Unidos