TReatment of Irritable bowel syndrome using Titrated ONdansetron Trial

ottingham University Hospitals NHS Trust0 个研究点目标入组 80 人开始时间: 2017年10月2日最近更新: 2023年3月20日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 80

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31429811 protocol (added 21/08/2019) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36866724/ (added 06/03/2023)

研究设计

研究类型: Interventional

入排标准

性别: All

入选标准

•1. Written (signed and dated) informed consent
•2. Considered fit for study participation
•3. Meeting Rome IV criteria (Appendix 1) for IBS-D
•4. Aged = 18 years
•5. Undergone standardised workup to exclude the following alternative diagnoses
•5.1. Microscopic colitis (colonoscopy or flexible sigmoidoscopy)
•5.2. Bile acid diarrhoea (SeHCAT results of > 10% or C4 results of <19 ng/ml or failed 1 week trial of a bile acid binding agent [colestyramine 4g t.d.s., colesevelam 625mg t.d.s. or equivalent]) within previous 5 years)
•(Note: Cholecystectomy will not be an exclusion criterion if bile acid diarrhoea has been excluded. Patients with SeHCAT values of 5-10% will be eligible if they fail to respond to a 1 week trial of bile acid binding agent (see above))
•5.3. Lactose malabsorption
•5.4. Coeliac disease (tTG or duodenal biopsy)
•6. Patients of childbearing potential or with partners of childbearing potential must agree to use methods of medically acceptable forms of contraception during the study and for 90 days after completion of study drug, (e.g. implants, injectable, combined oral contraceptives, barrier methods, true abstinence (when this is in line with the preferred and usual lifestyle of the patient) or vasectomised partners).
•7. For women of childbearing potential, a negative pregnancy test should be performed within 72 hours of confirmation of eligibility
•8. Weekly average worst pain score during 2-week screening period meets inclusion criteria
•9. Stool consistency during 2-week screening period meets inclusion criteria
•* Inclusion criteria 8 & 9 will be assessed after the patient has completed the 14-day daily stool and pain diary and returned the results at visit 2

排除标准

•1. Gastrectomy
•2. Intestinal resection
•3. Other known organic GI diseases (e.g. Inflammatory bowel disease – Crohns disease, Ulcerative colitis, coeliac disease)
•4. Unable or unwilling to stop restricted medication including regular loperamide, antispasmodics (e.g. buscopan, mebeverine, peppermint oil, alverine citrate), eluxadoline, tricyclic antidepressant doses >30mg/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. Intermittent loperamide will be permitted but only as rescue medication
•5. QTc interval =450msec for men and =470msec for women. Assessed within the last 3 months by a 12-lead ECG
•6. Previous chronic use of Ondansetron or contraindications to it (rare as per BNF)
•7. Pulse, Blood pressure, FBC or LFTs outside the normal ranges according to the site’s local definition of normal. Assessed within the last 3 months. Note: Minor rises in ALT (<2 x upper limit of normal) will be acceptable but the patient’s GP will be informed if they remain elevated at end of the study
•8. Women who are pregnant or breastfeeding
•9. Currently participating or who have been in an IMP trial in the previous three months where the use of the IMP may cause issues with the assessment of causality in this study
•10. Currently taking SSRIs or tricyclic antidepressants (unless at a stable dose for at least 3 months and with no plan to change the dose during the study)
•11. Currently taking and unwilling or unable to stop any of the prohibited medications.
•(Prohibited medications – Apomorphine and Tramadol which interact with ondansetron Caution should be taken with patients on QT prolonging drugs and cardio toxic drugs. These patients should be reviewed by the PI to determine if they are suitable for the study.
•12. Stool consistency during 2-week screening period does not meet inclusion criteria

研究者

发起方

ottingham University Hospitals NHS Trust

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