NCT02392546撤回2 期
A Single Center, Placebo-controlled Trial to Evaluate the Effects of Elobixibat in Colonic Motor Functions in Patients With Chronic Idiopathic Constipation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Postprandial Colonic Tone
研究概览
简要总结
This is a randomized trial of 36 otherwise healthy patients with chronic idiopathic constipation. The purpose of the study is to compare the effects of daily single-dose oral elobixibat and placebo for 7 days on colonic motor effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •Male or female 18-65 years of age
- •Body Mass Index of 18-40 kg/m2
- •Diagnosis of constipation for 12 or more weeks with symptom onset at least 6 months prior to the diagnosis and insufficient criteria to fulfill a diagnosis of irritable bowel syndrome (IBS), as defined by the Rome III criteria for Functional Constipation
- •Stable concomitant medications defined as no changes in regimen for at least 2 weeks prior to the trial period
排除标准
- •Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal (GI) disorders.
- •Use of drugs or agents within the past 2 weeks that alter GI transit including laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, selective serotonin reuptake inhibitor and newer antidepressants
- •Use of drugs or agents within the past 2 weeks that may add drowsiness and central nervous system (CNS) depression such as barbiturates, benzodiazepines, ethanol, lithium, opioids, buspirone, antihistamines, muscle relaxants, and other CNS depressants
- •The patient has a history of bariatric surgery for treatment of obesity; surgery to remove a segment of the GI tract; or surgery of the abdomen, pelvic or retroperitoneal area during the 6 months prior to Screening; or appendectomy or cholecystectomy 3 months prior to screening; or other major surgery 1 month prior to Screening
- •Clinical evidence (including physical exam) of clinically significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the trial. Any candidate participants with such disorder mentioned will be referred to their general physician
- •The Hospital Anxiety and Depression Scale (HADS) will be used to exclude patients with significant affective disorders
研究组 & 干预措施
Elobixibat 10 mg
Experimental
elobixibat
干预措施: elobixibat (Drug)
Elobixibat 15 mg
Experimental
elobixibat
干预措施: elobixibat (Drug)
Elobixibat 20 mg
Experimental
elobixibat
干预措施: elobixibat (Drug)
Placebo
Placebo Comparator
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Postprandial Colonic Tone
时间窗: At Day 7
Change in postprandial tone relative to fasting
时间窗: At Day 7
Number of postprandial High Amplitude Propagated Contractions (HAPCs)
时间窗: At Day 7
次要结局
- Fasting colonic tone(At Day 7)
- Colonic sensation threshold for pain(At Day 7)
- Total 48h fecal bile acid excretion(At Day 4-6)
- Colonic sensation threshold for first sensation(At Day 7)
- Colonic sensation threshold for gas(At Day 7)
研究者
研究点 (1)
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