CTRI/2010/091/000290已完成3 期
Evaluation of efficacy and safety of SPIRU-211 in the treatment of chronic idiopathic constipation in the adult population: a randomized, double-blind, placebo-controlled, multi-center study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male or female patients aged between 18-70 years.
- •2.Patients having history of chronic constipation meeting Rome III diagnostic criteria.
- •3.Patients willing to give informed consent
排除标准
- •1.Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control.
- •2.History of mechanical obstruction, mega colon/mega rectum or a diagnosis of pseudo obstruction.
- •3.Hospitalization for any gastrointestinal or abdominal surgical procedure during the 3 months before the start of the study.
- •4.Patients having clinically significant cardiovascular, liver, lung, or other systemic disease; neurologic or psychiatric disorders; impaired renal function.
研究者
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