CTRI/2009/091/000682已完成3 期
An open label comparative, multicentric study to assess the efficacy and safety of fixed dose combination capsules of Omeprazole & Cinitapride ER in comparison with Omeprazole capsules in patients suffering from non-ulcer dyspepsia (NUD) or gastroesophageal reflux disease (GERD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- The change in the mean intensity score of the symptoms (overall and individual) at the end of the study (Week 4) as compared to the baseline (prior to initiation of the therapy i.e. Week 0)
研究概览
简要总结
This study is an open label, comparative, multicentric study comparing the safety and efficacy of fixed-dose combination capsules of Omeprazole & Cinitapride ER and Omeprazole capsules once daily before meals each for 4 weeks in 200 patients with non-ulcer dyspepsia (NUD) or gastroesophageal reflux disease (GERD) that will be conducted in India. The primary outcome measures will be the change in the mean intensity score of the symptoms (overall and individual) at the end of the study as compared to the baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of either sex 18 years of age (no upper age limit was mentioned in our Protocol for this clinical trial).
- •2.Established diagnosis of non-ulcer dyspepsia (NUD) or gastroesophageal reflux disease (GERD) with gastrointestinal symptoms of at least moderate intensity.
- •3.Informed consent of the patient / relative.
排除标准
- •1.Pregnancy and/or Lactation.
- •2.Patients with an increased gastrointestinal motility e.g. in patients with gastrointestinal hemorrhage, mechanical obstruction or perforation.
- •3.Patients with ulcerative dyspepsia and/or ulcerative gastritis.
- •4.Patients with severe cardiac, pulmonary, hepatic or renal disease.
- •5.Patients on concomitant medications known to prolong QT interval.
- •6.Patients on concomitant medications known to affect action of Cinitapride like anticholinergic agents such as scopolamine, psychotropic drugs, other dopaminergic agents, or hormones.
- •7.Patients with known hypersensitivity to Omeprazole or Cinitapride or any other proton pump inhibitors or any other prokinetic agents.
结局指标
主要结局
The change in the mean intensity score of the symptoms (overall and individual) at the end of the study (Week 4) as compared to the baseline (prior to initiation of the therapy i.e. Week 0)
时间窗: 1,2,3 & 4 weeks
次要结局
- (1)Improvement in the mean intensity score of the symptoms (overall and individual) as estimated on a weekly basis.((2)Percentage of patients experiencing complete resolution of symptoms of reduced gastrointestinal motility at the end of the study i.e. 4 weeks.)
研究者
研究点 (5)
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