CTRI/2010/091/000586已完成3 期
A comparative, randomized, open label, parallel group, multicentric, clinical study to Evaluate the Efficacy, Safety and Tolerability of Lubiprostone Soft Gelatin capsules 24 mcg Vs Bisacodyl tablet 10 mg in the patients with chronic constipation.
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. Patient with clinical diagnosis of chronic constipation
- •2. Written informed consent by patient participating in the trial
排除标准
- •1. Adult patients <18 years of age of either sex
- •2. History of hypersensitivity to the study drug or related products
- •3. Significant history or presence of gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications
- •4. Any clinical significant illness during the 1 week prior to day 1 of this study
- •5. Participation in a clinical trial with an investigation drug within 30 days proceeding day 1 of this study
- •6. Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study
研究者
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