Efficacy of antipsychotic for the treatment of people suffering from Irritable Bowel Syndrome with Diarrhoea

Not Applicable

• Conditions: Health Condition 1: K580- Irritable bowel syndrome with diarrhea

• Registration Number: CTRI/2020/07/026666
• Lead Sponsor: Ahana Hospitals LLP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is to ascertain whether 12â??weeks of Chlorpromazine increases the FDA-defined responder rate (in relation to abnormal defaecation and abdominal pain) compared with placebo.Timepoint: Baseline,4 weeks , 8 weeks ,12 weeks

Secondary Outcome Measures

Name	Time	Method
a)Stool consistency and abdominal pain (measured by diary and daily text message) <br/ ><br> <br/ ><br>b)Stool frequency, urgency of defaecation, and use of rescue medication (defined as the use of loperamide) over 12â??weeks of treatment and the answer to the question â??Overall, have you had satisfactory relief from your IBS symptoms in the past week?â?? (measured by diary); <br/ ><br> <br/ ><br>c)IBS symptom severity (measured by the Irritable Bowel Syndrome Severity Scale <br/ ><br>Timepoint: baseline and at the end of the study