ISRCTN85156844已完成3 期
A phase III, randomised, study of Aspirin and Esomeprazole Chemoprevention in Barrett's Metaplasia (BM)
niversity of Oxford (UK)0 个研究点目标入组 2,513 人开始时间: 2005年2月15日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,513
研究概览
简要总结
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30057104
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Inclusion criteria as of 24/08/2016:
- •1. Patients aged over 18 years
- •2. Circumferential Barrett’s metaplasia of at least 1 cm in length (=C1M1) or a tongue of Barrett’s metaplasia of at least 2 cm in length (=C0M2) (irrespective of the presence now or historically of histologically proven intestinal metaplasia)
- •3. Patient?s able to give written consent
- •4. Patient?s with World Health Organization (WHO) activity profile of 0 or 1 i.e. fully active and self-caring
- •Inclusion criteria from 22/05/2007 to 24/08/2016:
- •1. Patients aged over 18 years
- •2. Patient with circumferential Barrett?s Metaplasia at least 1 cm long, and histologically proven intestinal metaplasia in at least one sample
- •3. Patient?s able to give written consent
- •4. Patient?s with World Health Organization (WHO) activity profile of 0 or 1 i.e. fully active and self-caring
- •Inclusion criteria provided at time of registration:
- •1. Male between 40 - 75 years
- •2. At least 2 cm from the gastro-oesophageal junction of circumferential BM (histologically proven by intestinal metaplasia in at least one sample)
- •3. Able to give written consent
- •4. World Health Organization (WHO) activity profile of 0 i.e. fully active and self-caring
排除标准
- •Exclusion criteria as of 24/08/2016:
- •1. Patients with high grade dysplasia or carcinoma at enrolment
- •2. Medical conditions which would make completing endoscopies or completing the trial difficult, including:
- •2.1. Frequent transient ischaemic attacks (3 or more) or severe cerebral vascular accident in the previous 6 months (patients answering yes were eligible for the PPI-only (non-aspirin) arms of the trial)
- •2.2. Severe respiratory disease with arterial oxygen saturation of less than 90% at rest
- •2.3. Severe ischaemic heart disease (exercise tolerance less than 100 yards or life expectancy < 4 years) or myocardial infarction in the previous 3 months
- •2.4. Severe inflammatory bowel disease requiring at least one hospital admission of 5 days in the last year or bowels open > 6 times/day
- •3. Patients with absolute contraindications to PPIs, aspirin or their excipients i.e. allergies, ulcers, renal impairment or use of oral anticoagulants.
- •4. Pregnant or lactating women will not undergo endoscopy and may be given dispensation to stop drug therapy for a year. This should be discussed with the Trial Office.
- •Exclusion criteria from 22/05/2007 to 24/08/2016:
- •1. Patients with high grade dysplasia or carcinoma at enrolment;
- •2. Patients with medical conditions which would make completing endoscopies or the trial difficult to complete including:
- •2.1. Previous transient ischaemic attacks or cerebral vascular disease
- •2.2. Severe respiratory disease
- •2.3. Severe ischaemic heart disease or myocardial infarction in the previous 6 months
- •2.4. Inflammatory bowel disease
- •3. Patients who are on continuous aspirin or non-steroidal anti-inflammatories or Cox-2 inhibitors (more than 3 courses/year)
- •4. Patient?s with absolute contraindications to PPIs, aspirin or their excipients such as allergies, ulcers, renal impairment or use of oral anticoagulants
- •5. Pregnant or lactating women
- •Exclusion criteria provided at time of registration:
- •1. High grade dysplasia or carcinoma at enrolment
- •2. Medical conditions which would make endoscopy or the trial difficult or failure to complete including transient ischaemic attacks or cerebral vascular disease, severe respiratory disease, severe ischaemic heart disease or recent myocardial infarction or inflammatory bowel disease
- •3. Patients who are on continuous aspirin or non-steroidal drugs (more than 3 courses/year)
- •4. Absolute contraindications (ulcers) or allergies to PPIs or aspirin such as renal impairment and oral anticoagulants
研究者
相似试验
已完成
3 期
SUPREMO, an MRC Phase III randomised trial to assess the role of adjuvant chest wall irradiation in 'intermediate risk' operable breast cancer following mastectomyCancerBreast cancerISRCTN61145589niversity of Edinburgh, Lothian Health Board and the Common Services Agency (UK)1,688
终止
3 期
HYMN: a trial comparing hyperthermia and mitomycin chemotherapy with a second BCG treatment, or other standard treatment, for bladder cancer that has come backCancerISRCTN85785327niversity College London (UK)242
已完成
3 期
A phase III, randomised, controlled trial for the treatment of HIV-associated cryptococcal meningitis: oral fluconazole plus flucytosine or one week amphotericin B-based therapy vs two weeks amphotericin B-based therapyISRCTN45035509St George's University of London (UK)680
进行中（未招募）
1 期
AspECT - A phase III, randomised study of aspirin and esomeprazole chemoprevention in Barrett's metaplasia & oesophagitis. - AspECTEUCTR2004-003836-77-GBniversity of Oxford2,535
已完成
3 期
CLEOPATRA study: the clinical efficacy and safety of light-masks at preventing dark adaptation in the treatment of non-centre-involving diabetic macular oedemaTopic: Diabetes Research Network, EyeSubtopic: Both, Other, Eye (all Subtopics)Disease: Retinopathy, Diabetic Control, Other, Retina (including diabetes)Nutritional, Metabolic, EndocrineISRCTN85596558Moorfields Eye Hospital NHS Foundation Trust (UK)300