NCT01707667已完成4 期
An Open-label, Randomized, Crossover, Reader-blinded Study to Investigate the Effect of Prucalopride and Polyethylene Glycol 3350 on Colon Motility With Intramural Manometry in Subjects With Chronic Constipation
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 13
- 试验地点
- 3
- 主要终点
- The Number of High-Amplitude Propagating Contractions (HAPC)
研究概览
简要总结
To evaluate the different effects of prucalopride and PEG 3350 + electrolytes on colon motor activity in subjects that are chronically constipated.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic constipation
- •Male or female ages 18-75 years
- •Non-pregnant, non-lactating female
排除标准
- •Drug-induced constipation
- •Subjects suffering from secondary causes of chronic constipation, such as:
- •Endocrine disorders, e.g. hypopituitarism, hypothyroidism, hypercalcemia, pseudohypoparathyroidism, pheochromocytoma or glucagon-producing tumors, unless these are controlled by appropriate medical therapy.
- •Metabolic disorders, e.g. porphyria, uremia, hypokalemia or amyloid neuropathy, unless these are controlled by appropriate medical therapy
- •Neurological disorders, e.g. Parkinson's disease, cerebral tumors, cerebrovascular accidents, multiple sclerosis, meningocele, aganglionosis, hypoganglionosis, hyperganglionosis, autonomic neuropathy or neuropathy due to chemotherapy, spinal cord injury, Chaga's disease, or major depression
- •Subjects with insulin-dependent diabetes mellitus
- •Rectal evacuation disorder/outlet obstruction
- •Subjects with intestinal perforation or obstruction
- •Severe renal impairment
- •Subjects with a history of alcohol or drug abuse
- •Subjects with lactose intolerance
- •Subjects with clinically significant cardiac, vascular, liver, pulmonary, endocrine, neurological or psychiatric disorders
研究组 & 干预措施
Prucalopride
Experimental
干预措施: prucalopride (Drug)
PEG 3350
Active Comparator
干预措施: PEG 3350 (Drug)
结局指标
主要结局
The Number of High-Amplitude Propagating Contractions (HAPC)
时间窗: over 12 hours post-dose
Manometry recordings were read by an experienced gastroenterologist who was blinded to the treatment each subject received. The tracings were analyzed using computer-based validated software. HAPC and manometry data were available for every sensor as well as average values for each HAPC and manometry time point. The primary outcome analysis of HAPC data used the following threshold: Mean amplitude ≥100mmHg and extension ≥20cm (9 sensors).
次要结局
- The Mean Amplitude of HAPC(over 12 hours post-dose)
- Time to First HAPC(over 12 hours post-dose)
- Motility Index(over 12 hours post-dose)
- Propagation Velocity of HAPC(over 12 hours post-dose)
- Duration of HAPC(over 12 hours post-dose)
- Area Under the Concentration Curve (AUC) of All HAPCs(over 12 hours post-dose)
研究者
研究点 (3)
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