CTRI/2020/07/026666尚未招募未知
A randomised trial of chlorpromazine for the treatment of irritable bowel syndrome with diarrhoea
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
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
- •Patients must fulfil all of the following criteria:
- •1.Meet Rome IV criteria for IBS-D
- •2.Age 18 - 50â??years
- •3.Patients of childbearing potential or with partners of childbearing potential must agree to use methods of medically acceptable forms of contraception during the trial and for 90â??days after completion of trial medication
- •4.Women of childbearing potential must test negative for pregnancy within 72â??h of confirmation of eligibility
- •5.Weekly average worst pain scoreâ??>=â??30 on a 0â??100-point scale
- •6.Stools with a consistency of 6 or 7 on the Bristol Stool Form Score (BSFS) for 2 or more days per week
排除标准
- •1.Gastrectomy
- •2.Intestinal resection;
- •3.Other known organic gastrointestinal diseases (e.g. inflammatory bowel disease (Crohnâ??s disease, ulcerative colitis));
- •4.Unable or unwilling to stop restricted medication including regular loperamide, antispasmodics (e.g. buscopan, mebeverine, peppermint oil, alverine citrate), eluxadoline, tricyclic antidepressant doses >â??30â??mg/day or other drugs likely in the opinion of the investigator to alter bowel habit. These medicines should be discontinued for a 7-day washout period prior to registration;
- •5.QTc intervalâ??>=â??450â??msec in men orâ??>=â??470â??msec in women (assessed within the last 3â??months by electrocardiogram (ECG));
- •6.Pulse, blood pressure, laboratory-tested blood values outside the normal ranges according to the siteâ??s local definition of normal (assessed within the last 3â??months). Note minor rises in alanine aminotransferase (ALT) ( <â??2 Ã? upper limit of normal) will be acceptable, but the patientâ??s General Practitioner (GP) will be informed if ALT remains elevated at the end of the trial;
- •7.Women who are pregnant or breastfeeding;
- •8.Patients currently or previously participating in a trial of an investigational medicinal product (IMP) in the previous 3 months, where the use of the IMP may cause issues with the assessment of causality in this trial;
- •9.Patients with only stools of consistency 7 on the BSFS for 7â??days a week.
- •10.Patients taking QT-prolonging or cardiotoxic drugs will be reviewed by the local Principal Investigator (PI) to determine whether they are suitable for the trial.
研究者
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