EUCTR2019-000324-17-GB进行中（未招募）1 期
Amitriptyline at Low-dose and Titrated for Irritable Bowel Syndrome as Second-line Treatment (The ATLANTIS study): A Double-blind Placebo-controlled Trial - The ATLANTIS study v1.0
niversity of Leeds0 个研究点目标入组 518 人开始时间: 2019年11月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 518
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
- 性别
- All
入选标准
- •1. A diagnosis of IBS (of any subtype of stool pattern [diarrhoea, constipation, mixed]) in their primary care record, and fulfilling the Rome IV criteria;
- •2. Age =18 years;
- •3. Ongoing symptoms, defined as an IBS severity scoring system (IBS-SSS) score of =75 at screening, despite having tried dietary changes and first-line therapies as defined by NICE (antispasmodics [e.g. mebeverine], fibre supplements [e.g. fybogel], or anti-diarrhoeals[e.g. loperamide]), assessed at screening via patient self-report;
- •4. A normal haemoglobin, total white cell count (WCC), and platelets within the last 6 months prior to screening;
- •5. A normal CRP within the last 6 months prior to screening;
- •6. Exclusion of coeliac disease, via anti-tTG antibodies, as per NICE guidance;
- •7. No evidence of active suicidal ideation, as determined by three clinical screening questions below, and no recent history of self-harm (an episode of self-harm within the last 12 months prior to screening).
- •(i)Whether the patient has experienced any thoughts of harming themselves,
- •or ending their life in the last 7-10 days?
- •(ii)Whether the patient currently has any thoughts of harming themselves or
- •ending their life?
- •(iii) Whether the patient has any active plans or ideas about harming
- •themselves, or taking their life, in the near future?
- •8. If female, must be:
- •a. postmenopausal (no menses for 12 months without an alternative medical cause), or;
- •b. surgically sterile (hysterectomy, bilateral salpingectomy or bilateral oophorectomy), or;
- •c. using highly effective contraception (must agree to be continued for 7 days after the last dose of the investigational medicinal product).
- •9.Able to complete questionnaires and trial assessments;
- •10.Able to provide written informed consent.
- •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 448
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •1. Aged >60 years and with no GP review in the 12 months prior to screening;
- •2. Meeting locally adapted NICE 2-week referral criteria for suspected lower gastrointestinal cancer;
- •3. A known documented diagnosis of inflammatory bowel disease or coeliac disease;
- •4. A previous diagnosis of colorectal cancer;
- •5. Patients currently participating in or who have been involved in any other CTIMP trial in the previous 3 months prior to screening;
- •6. Pregnant or breastfeeding;
- •7. Planning to become pregnant within the next 18 months;
- •8. Current use of a TCA, or use of a TCA within the last 2 weeks prior to randomisation, for another indication;
- •9. Allergy to TCAs;
- •10. Other contraindications to the use of TCAs, including patients with any of the following:
- •taking monoamine oxidase inhibitors (MAOIs), or receiving them within the last 2 weeks;
- •already prescribed a TCA for the treatment of depression;
- •previous myocardial infarction;
- •recorded arrhythmias, particularly heart block of any degree, prolonged Q-T interval on ECG;
- •severe liver disease;
- •porphyria;
- •congestive heart failure;
- •coronary artery insufficiency;
- •receiving concomitant drugs that prolong the QT interval (e.g. amiodarone, terfenadine, or sotalol).
- •Other cautions to the use of TCAs will not be an exclusion, but these will be recorded at screening and clarified with the patient’s GP and the lead GP in each hub prior to study entry.
研究者
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