A Phase IIa Pharmacodynamic Study of Antagonism of Irritable Bowel Syndrome (IBS) Symptoms by GW876008, a Corticotrophin Releasing Factor 1 Receptor Antagonist (CRF1-RA)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Percent change from Baseline in Laser Doppler regional Rectal Mucosal Blood Flow (RMBF) measured in response to physiological stress (cold water pressor test)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Percent change from Baseline in Laser Doppler regional Rectal Mucosal Blood Flow (RMBF) measured in response to physiological stress (cold water pressor test)
时间窗: Baseline (pre-dose) and Study Days 1, 2 and 3
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.
Percent Change from Baseline in Laser Doppler regional RMBF measured in response to psychological stress (dichotomous listening test)
时间窗: Baseline (pre-dose) and Study Days 1, 2 and 3
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.
次要结局
- Number of participants with abnormal clinical chemistry data of clinical concern(Up to Week 14)
- Change from Baseline in RMBF at 90 minutes post-dose(Baseline (pre-dose) and Study Days 1, 2 and 3)
- Number of participants with abnormal hematology data of clinical concern(Up to Week 14)
- Participant perceived stress as assessed by a Visual Analogue Scale(Study Days 1, 2 and 3)
- Systemic autonomic nervous system response as assessed by systolic blood pressure (SBP) and diastolic blood pressure (SBP)(Up to Week 14)
- Systemic autonomic nervous system response as assessed by heart rate (HR).(Up to Week 14)
- Percent change from Baseline in participant reported threshold for pain as a measure to assess Visceral (rectal) electro sensitivity(Baseline (pre-dose) and Study Days 1, 2 and 3)
- Percent change from Baseline in participant reported threshold for perception of an electrical stimulus as a measure to assess Visceral (rectal) electro sensitivity(Study Days 1, 2 and 3)
- Number of participants with adverse events (AE) and serious adverse events (SAE)(Up to Week 14)