A Multicentre, Open-label Extension Phase to Study the Long-term Safety and Efficacy of Itopride HCl in Patients Suffering From Functional Dyspepsia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 主要终点
- Long-term safety
研究概览
简要总结
Itopride is a compound already marketed in Japan and in some countries of Eastern Europe under the name of Ganaton. It is used to treat symptoms of functional dyspepsia. Patients suffering from this condition have difficulties digesting food. Patients feel full after eating, they have bloating and have stomach pain. The goal of this study is to see if Itopride helps to relieve the symptoms of functional dyspepsia on a long-term basis.
详细描述
All patients having completed study ITOFD04-01 will be offered to continue to be treated with itopride for a period of up to one year in duration. A target of 300 patients will be followed up for 6 months. Of these, a target of 100 patients will be kept on treatment for an additional 6 months.
Patients will need to come to the clinic for evaluations every 8 weeks during the trial. Evaluations done at these visits will include: lab tests, evaluation of the heartburn condition, and a questionnaire needed to be completed by the patient to see if the drug is helpful in relieving their symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients must have completed the 8 week double-blind study ITOFD04-01
- •Female patients must not be pregnant (must have a negative serum pregnancy test)
排除标准
- •Patients with any newly occurring medical condition which was an exclusion criterion at ITOFD04-01 study entry
结局指标
主要结局
Long-term safety
次要结局
- Long-term relief of symptoms