NCT00376896已完成1 期
A Phase IIa Experimental Medicine Study Assessing Alterations in Regional Cerebral Blood Flow by Functional Magnetic Resonance Imaging (fMRI) in Female IBS Patients and Healthy Controls Following Single Doses of GW876008, a Corticotrophin Releasing Factor 1 Receptor Antagonist (CRF1-RA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Signal reductions in the amygdala during viewing of emotional faces and during abdominal pain threat as measured by the fMRI.
研究概览
简要总结
This is a three-period crossover study to compare GW876008 and placebo to see if GW876008 will normalise blood flow responses after different emotional stimuli.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The subject should not have been taking and medication for the treatment of IBS for 1 month prior to the study
- •Negative serum pregnancy tests (serum a-HCG negative) at Screening (Visit 1), and negative urine pregnancy tests at Visits 1, 2, 3 prior to study medication dose.
- •Non-tobacco user (abstinence from tobacco use for at least 1 month before the start of the study).
- •Normal electrocardiogram (subjects must have no clinically significant abnormalities on a 12-lead ECG at screen).
排除标准
- •Subjects who are pregnant or nursing.
- •Current evidence, or history of (at any time in the past) of a biochemical or structural abnormality of the digestive tract. including (but not limited to): inflammatory bowel disease (Crohn's disease or ulcerative colitis); functional dyspepsia; lactose intolerance, not on a stable diet; Celiac Disease
- •Subjects who are taking NSAIDs on a regular basis or within 48 hours of a study day.
- •The subject has a positive pre-study urine drug/alcohol screen.
- •A positive pre-study HIV 1 / 2, Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of the start of the study.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Other)
GW876008 20mcg
Experimental
GW876008 20mcg
干预措施: GW876008 20mcg (Drug)
GW876008 200mcg
Experimental
GW876008 200mcg
干预措施: GW876008 200mcg (Drug)
结局指标
主要结局
Signal reductions in the amygdala during viewing of emotional faces and during abdominal pain threat as measured by the fMRI.
时间窗: throughout the study
次要结局
- Questionnaires to assess IBS symptoms and anxiety(throughout the study)
研究者
研究点 (1)
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