NCT01027260已完成2 期
A Randomized, Placebo Controlled Study on the Efficacy of Itopride HCI on Irritable Bowel in Patients of Irritable Bowel Syndrome With Constipation (IBS-C)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 268
- 试验地点
- 4
- 主要终点
- Patients will be asked a simple but well validated question "If there is a satisfactory relief of the symptoms"
研究概览
简要总结
Patients suffering from Irritable Bowel Syndrome with predominant constipation will be provided with the study medication. The study medication will be evaluated for its efficacy in relieving the symptoms
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient fulfilling the Rome III criteria for IBS-C
- •Signed informed consent at screening visit
排除标准
- •Patients having significant diarrhea at least 25% of the time during the past 3 months
- •Patients having alarm symptoms or signs
- •Chronic diarrhea
- •History of gastrointestinal haemorrhage, mechanical obstruction or perforation
- •Patient with clinically relevant ECG abnormalities (prolonged QT interval)
- •Active psychiatric disorder that would interfere with the study objectives
- •Health conditions (e.g. age related impairment of cognitive functions) that would interfere with the study objectives or might impair the compliance of the patient
- •Severe hepatic, renal, cardiac, metabolic, haematological or malignant diseases (including prolactin dependent tumours) or clinically relevant deviations in laboratory values (AST/ALT greater than twice the upper limit of normal, serum creatinine * 2 mg/dl [177 µmol/l] according to the medical judgement of the investigator
- •Patient with hypokalemia (serum potassium < 3.5 mmol/l).
- •History of any known hypersensitivity to the ingredients of the investigational drug
- •Pregnancy or lactation
- •Women with childbearing potential who do not apply a medically accepted method of contraception.
研究组 & 干预措施
Itopride 50 mg
Active Comparator
干预措施: Itopride HCI 50 mg (Drug)
Itopride 100 mg
Active Comparator
干预措施: Itopride HCI 100 mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Patients will be asked a simple but well validated question "If there is a satisfactory relief of the symptoms"
时间窗: 2 weeks and 4 weeks after the start of the treatment
次要结局
- Subjects will be assessed based on Irritable Bowel Syndrome Severity Score (IBSSS).(2 weeks and 4 weeks after the start of the treatment)
- Safety based on the laboratory tests before and at the end of the treatment.(4 weeks during the treatment period and 4 weeks following post- therapy period.)
研究者
研究点 (4)
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