Double-Blind, Randomized, Placebo-Controlled Trial To Assess Efficacy And Safety Of R051619 (Cisapride 10 mg q.i.d.) Versus Placebo For The Improvement Of Symptoms Associated With Exacerbations Of Idiopathic Gastroparesis, After Failure Of Other Treatment Options
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 20
- 主要终点
- The average change from baseline in Gastroparesis Cardinal Symptoms Index (GCSI) score
研究概览
简要总结
The purpose of this study is to assess the effectiveness of cisapride in patients with a primary diagnosis of chronic gastroparesis (a stomach disorder) of unknown cause.
详细描述
This is a double-blind (neither the physician nor the patient will know the name of assigned treatment) study to determine the effectiveness of cisapride tablets compared to placebo tablets (a tablet identical in appearance to cisapride but does not contain active drug) in patients with a primary diagnosis of idiopathic gastroparesis (a disorder of unknown cause in which the stomach empties its contents very slowly into the small intestine for digestion. Symptoms of gastroparesis may include vomiting, nausea, early feeling of fullness after only a few bites of food, weight loss due to poor absorption of nutrients or low calorie intake, abdominal bloating, poor glycemic (blood sugar) control, lack of appetite, and pain in the stomach area. Patients will take study drug (one 10-mg tablet of cisapride, or one tablet of placebo), orally, 4 times a day, for a period of 8 weeks. Study drug will be taken approximately 15 minutes before each meal, and, with a beverage, before going to bed.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with nondiabetic idiopathic gastroparesis and having symptoms for at least 12 weeks in the preceeding 12 months
- •Experienced inadequate response, or intolerance to therapy to date
- •Have exacerbation of gastroparesis symptoms requiring medical attention
- •Demonstrate delayed gastric emptying as assessed by a [1-13C]-Sodium Acetate Breath Test within 14 days before randomization
排除标准
- •Received prior treatment with cisapride
- •Have a gycosylated hemoglobin (HbA1c) >7% and bloodglucose of 126 mg/dL (7.0 mmol/L) or greater at screening, as determined by clinical laboratory testing
- •Have any upper gastrointestinal (GI) pathology other than idiopathic gastroparesis that would require therapy other than that provided in this trial
- •Have any organic/neurological disease that is suspected to be causing gastroparesis
- •Currently vomiting, or receiving therapy for a severe exacerbation of gastroparesis, that would prevent the patient from receiving oral therapy or a diet
研究组 & 干预措施
001
Cisapride one 10 mg tablet 4 times a day for 8 weeks
干预措施: Cisapride (Drug)
002
Placebo one placebo tablet 4 times a day for 8 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
The average change from baseline in Gastroparesis Cardinal Symptoms Index (GCSI) score
时间窗: At baseline (Week 0) up to 8 weeks
次要结局
- The number and type of adverse events reported(From time of first dose to the last dose (up to 8 weeks))