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
- 试验地点
- 6
- 主要终点
- To evaluate the efficacy of fixed dose combination of Ispaghula Husk IP 3.5g and Lactitol Monohydrate BP 10g Granules in the treatment of Acute Idiopathic Constipation.
研究概览
简要总结
The study will be conducted after obtaining written informed consent from 200 subjects with Acute Idiopathic Constipation who will be enrolled and complete the protocol therapy of 7 days. The subjects will undergo medical screening during pre-study visit (Visit 1). Screening will include complete clinical evaluation (medical history, physical examination, record of height, weight and vital signs). Female subjects of child bearing capability will be subjected to a urine pregnancy test.Enrolled subjects will receive the medication for 7 days (Visit 2). At visit 3 (day 7) end of therapy efficacy, safety, tolerability and ADR monitoring will be done. Subjects are allowed to visit to investigator at any time point during the study.this study is open An Open label Prospective Non Comparative Phase III Study for Efficacy and Safety of FDC of Ispaghula Husk IP 3.5g and Lactitol Monohydrate BP 10g Granules, in the treatment of Acute Idiopathic Constipation. This study is done for the DCGI marketing approval and the product will be marketed in India after the clearance form the regulatory authorities
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
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.
结局指标
主要结局
To evaluate the efficacy of fixed dose combination of Ispaghula Husk IP 3.5g and Lactitol Monohydrate BP 10g Granules in the treatment of Acute Idiopathic Constipation.
时间窗: day 4
次要结局
- To evaluate the safety of fixed dose combination of Ispaghula Husk IP 3.5g and Lactitol Monohydrate BP 10g Granules in the treatment of Acute Idiopathic Constipation.(day 7)
- Proportion of subjects with full response to treatment at the end of follow up phase.2. The frequency of SBMs during 1st week of treatment;Time-to-first SBM(proportion of subjects with a SBM within 24 and 48 h of first study drug administration)