EUCTR2017-000533-31-GB进行中（未招募）1 期
TReatment of Irritable bowel syndrome using Titrated ONdansetron Trial - TRITON Trial v1.0
ottingham University Hospitals NHS Trust0 个研究点目标入组 400 人开始时间: 2017年7月18日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Patients must fulfil all of the following criteria.
- •1.Written (signed and dated) informed consent.
- •2.Considered fit for study participation.
- •3.Meeting Rome IV criteria for IBS-D (see Appendices)
- •4.Aged = 18 years
- •5.Undergone standardised workup to exclude the following alternative diagnoses
- •a) Microscopic colitis (colonoscopy or flexible sigmoidoscopy), within previous 2 years
- •b) Bile acid diarrhoea (SeHCAT results of > 10%, 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 criteria if bile acid diarrhoea has been excluded
- •c) Lactose malabsorption (In the opinion of the patient’s clinician. Suggested but not mandated methods to exclude lactose malabsorption as an alternative diagnosis include hydrogen breath test/milk challenge or failure to respond to lactose free diet).
- •d) Coeliac disease (tTG or duodenal biopsy)
- •6.Patients of child bearing potential or with partners of child bearing 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 child bearing potential, a negative pregnancy test should be performed within 72 hours of confirmation of eligibility.
- •8.Weekly average worst pain score = 30 points on a 0 to 100 point scale.
- •9.Any stools with a consistency of 6 or 7 on the Bristol Stool Form score (BSFS) for 2 - 6 days per week.
- •Inclusion criteria 8 & 9 will be assessed after the patient has completed the 14 day pre-treatment daily stool and pain diary and returned the results at visit 2.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 390
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Patients must not fulfil any of the following criteria:
- •1.Gastrectomy
- •2.Intestinal resection
- •3.Other known organic GI 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 >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.
- •Note: Intermittent loperamide will be permitted but only as rescue medication (see section 8.7)
- •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, laboratory 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 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.Patients 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 & 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. Patients with only stools of consistency 7 on the Bristol Stool Form score (BSFS) for 7 days a week. ^^
- •^^ Exclusion criterion 12 will be assessed after the patient has completed the 14 day pre-treatment daily stool and pain diary and returned at visit 2.
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