CTRI/2010/091/001106已完成3 期
Open label Prospective, Non Comparative, Phase III Study for Efficacy and Safety of FDC of Ispaghula Husk and Lactitol Monohydrate Granules,in the treatment of Acute Idiopathic 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
- •Subjects of both sexes , aged between 18-50 years
- •Subjects with acute idiopathic constipation(defined as presence of less than three stools per week and/or straining at stool for at least three months) who have one or more of the following symptoms associated with at least 25% of bowel movements (BMs) for at least 3 months prior to the baseline visit: very hard (little balls) and/or hard stools, a sensation of incomplete evacuation, or straining at defecation.
排除标准
- •Documented mechanical obstruction, megacolon/megarectum or a diagnosis of pseudoobstruction
- •Hypersensitivity to lactitol, Ispaghula Husk or any other constituents of the investigational product.
- •Known or suspected organic disorders of the large or small intestine.
- •Secondary causes of constipation.
- •Hospitalization for any gastrointestinal or abdominal surgical procedure during the 3 months before the start of the study.
- •Prior bowel resection.
- •Clinically significant cardiovascular, liver, lung, or other systemic disease; neurologic or psychiatric disorders.
- •Cancer within the past 5 yr
- •Women of childbearing potential who cannot use oral or implanted contraceptives or to have used a double-barrier method during the trial.
- •Breast feeding women.
- •Any other illness which could seriously effect the safety of subjects and /or the integrity of the study
- •Subjects who, within the past 30 days have participated in an investigational clinical study.
- •Subjects currently taking, or planning to take any of the following medications that are known to effect bowel habits:
- •Antidiarrheals
- •Antacids containing magnesium or aluminum salts
- •Anticholinergics
- •Antispasmodic agents
- •Erythromycin and other macrolides
- •Opiods/narcotic analgesics
- •Prokinetics
- •Serotonin re-uptake inhibitors or tricyclic antidepressants
- •Calcium antagonists.
研究者
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