CTRI/2020/07/026666尚未招募不适用
A randomised trial of chlorpromazine for the treatment of irritable bowel syndrome with diarrhoea
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The primary outcome measure is to ascertain whether 12 weeks of Chlorpromazine increases the FDA-defined responder rate (in relation to abnormal defaecation and abdominal pain) compared with placebo.
研究概览
简要总结
Irritable bowel syndrome with diarrhoea (IBS-D) affects up to 4 % of the population. The symptoms include frequent, loose or watery stools with associated urgency, resulting in a marked reduction of quality of life and loss of productivity. Chlorpromazine,a D2 receptor antagonist with combined action in Histaminic and muscarinic receptor which is widely used as an antipsychotic drug with a notorious side effect such as constipation can be used in the treatment of IBS-D at lower doses
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients must fulfil all of the following criteria: 1.Meet Rome IV criteria for IBS-D 2.Age
- •50 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 90 days after completion of trial medication 4.Women of childbearing potential must test negative for pregnancy within 72 h of confirmation of eligibility 5.Weekly average worst pain score ≥ 30 on a 0–100-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 (Crohn’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 > 30 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 interval ≥ 450 msec in men or ≥ 470 msec in women (assessed within the last 3 months by electrocardiogram (ECG)); 6.Pulse, blood pressure, laboratory-tested blood values outside the normal ranges according to the site’s local definition of normal (assessed within the last 3 months).
- •Note minor rises in alanine aminotransferase (ALT) (< 2 × upper limit of normal) will be acceptable, but the patient’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 7 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.
结局指标
主要结局
The primary outcome measure is to ascertain whether 12 weeks of Chlorpromazine increases the FDA-defined responder rate (in relation to abnormal defaecation and abdominal pain) compared with placebo.
时间窗: Baseline,4 weeks , 8 weeks ,12 weeks
次要结局
- a)Stool consistency and abdominal pain (measured by diary and daily text message)(b)Stool frequency, urgency of defaecation, and use of rescue medication (defined as the use of loperamide) over 12 weeks of treatment and the answer to the question “Overall, have you had satisfactory relief from your IBS symptoms in the past week?†(measured by diary);)
研究者
研究点 (1)
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