CTRI/2020/09/027980已完成Unknown
A Prospective, Single arm, Multicentric, Post-marketing Observational Study to Evaluatethe Effectiveness and Safety of Fixed Dose Combination of Mebeverine Hydrochloride135 mg and Chlordiazepoxide 5 mg Tablets in the Management ofIrritable Bowel Syndrome
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- The primary endpoint of the study is change in mean IBS SSS total score
研究概览
简要总结
This is an 8-week prospective, single-arm, multicentric PMOS to evaluate the effectiveness and safety of FDC of Mebeverine hydrochloride 135 mg and Chlordiazepoxide 5 mg in the management of IBS. Approximately 60 patients with confirmed diagnosis of IBS (available from past medical records), or newly diagnosed patients who have not been taking any medications, in past 3 months for IBS, have anxiety symptoms (HAM-A score [score of at least 18]), and have been prescribed the study drug as a part of the routine practice will be eligible to participate in this study. The study will involve clinical assessments of patients at Screening/Baseline Visit (Day 1, Visit 1), and at or closest to 4 Week (Visit 2), and 8 Week (Visit 3, End of Study [EOS] Visit) after treatment with study drug (Colospa Xâ„¢). Croissance Clinical Research is providing DM support to the study.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female patients above 18 up to 60 years Both male and female (of childbearing potential) patients willing to use appropriate method of contraception as per investigator’s discretion, throughout the study.
- •Female of childbearing potential must have a negative pregnancy test and be non-lactating at baseline Patients who are newly diagnosed with IBS along with anxiety and are recommended the study drug as per investigator discretion Patient willing to sign Patient Authorization Form (PAF).
排除标准
- •Hypersensitivity to the active substances or any of the study drug excipients Severe respiratory insufficiency, organic brain damage, sleep apnea syndrome, severe, acute or chronic hepatic insufficiency (risk of occurrence of encephalopathy), myasthenia gravis, chronic psychosis, major depressive episodes, phobic or obsessional states, or dementia Other preexisting GI disorders, patients with history of GI surgery, abnormal upper, and lower GI endoscopy finding Family history of colon cancer or inflammatory bowel disease Patients with alarm symptoms (red flag or the symptoms that discriminates lower GI organic diseases from IBS) (Hammer et al 2004); e.g., a.Blood in stool b.Nighttime symptoms that wakes a person c.Unintentional weight loss d.Change in typical IBS symptoms will be noted.
- •E.g. new and/or different pain History of chronic alcoholism or other drug related dependency History of excessive alcohol intake (women: ≥8 drinks per week; men: ≥15 drinks per week)a History of addiction to narcotics Patient who excessively drives or operate hazardous machinery Any past or present conditions or diseases that investigator considers not appropriate to enter the study Current use or past history of any medication in last 3 months which might interfere with the action of the study drug Pregnant and lactating women.
结局指标
主要结局
The primary endpoint of the study is change in mean IBS SSS total score
时间窗: from baseline to week 8.
次要结局
- Socio-demographic profile of patients with IBS in terms of(Age, Gender, BMI, Socio economic status (Ghosh and Ghosh 2009), Marital status , Residence, Lifestyle habits, Diet habits,)
- Change in mean IBS SSS total score(from baseline to week 4)
- Change in mean IBS-SSS score of abdominal pain, number of days of abdominal pain, severity of abdominal distention, dissatisfaction with bowel habits, and interference with QOL(from baseline to Weeks 4 and 8)
- Number and percentage of 1IBS SSS responders(at Week 4 and Week 8)
- Change in mean IBS 36 score(from baseline to Week 8)
- Number and percentage of 2IBS 36 responders(at Week 8)
- Change in anxiety total scores on HAM A from baseline to Weeks 4 and 8(1IBS SSS responders: Patients are said to be IBS SSS responders when their overall symptom severity on the)
研究者
研究点 (5)
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