EUCTR2013-003187-31-GB进行中（未招募）1 期
Misoprostol for the Healing of Small Bowel Ulceration in Patients with Obscure Blood Loss while Taking Low-Dose Aspirin or Non-Steroidal Anti-inflammatory Drugs [MASTERS Trial] - Misoprostol for healing of small bowel ulcers in aspirin & NSAID users
HS Greater Glasgow & Clyde0 个研究点目标入组 104 人开始时间: 2019年6月11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
- 104
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
- •Inclusion criteria
- •Obscure occult gastrointestinal bleeding:
- •Iron deficiency anaemia (ferritin <100 ug/l, hemoglobin [Hb] 7–12 g/dl [female] or 7–13 g/dl [male])
- •Normal upper endoscopy and colonoscopy
- •Taking low-dose aspirin (75-325m/ day) or NSAIDs
- •Drop in haemoglobin, > 2gm/dl, over two measurements taken within 3 months of the screening visit, in the absence of potential or actively bleeding lesion detectable on upper endoscopy or colonoscopy.
- •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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •Exclusion criteria
- •Any of the following is regarded as criterion for exclusion from the study:
- •1.Systemic disease that is unstable at the time of randomisation [unstable vital signs (pulse, blood pressure, respiratory rate, temperature, etc); ongoing non-gastrointestinal investigations; frequent (more than once/ week) modifications to treatment]
- •2.Upper gastrointestinal lesions: oesophageal varices; erosive oesophagitis; oesophageal stricture; oesophageal or gastric neoplasms; pyloric stenosis; peptic ulcers; vascular malformations.
- •3.Colonic disorders: neoplasms or adenomatous polyps; inflammatory bowel disease; vascular malformations; actively bleeding diverticular disease
- •4.Pregnancy, lactation, or women of child-bearing potential not using two contraceptive methods, one of which must be highly effective, or planning pregnancy. Women Not of Childbearing Potential” are defined as those women who are postmenopausal or permanently sterilised (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy). Women of Childbearing Potential” are defined as any female who have experienced menarche and do not meet the criteria for Women Not of Childbearing Potential”. Preferred Highly Effective Contraceptive Methods are those with lower use dependency and include implants, injectables, and some intrauterine devices (IUDs). Combined oral contraceptives, sexual abstinence or vasectomised partner (provided that partner is sole sexual partner and that surgical success has been confirmed in the vasectomised partner) may also be used. Other contraception methods such as barrier contraception with our without spermicide may be used in combination with a highly effective method of contraception.
- •5.Hypotension: systolic blood pressure <100-mm Hg.
- •6.History of oesophageal, gastric or duodenal surgery, excluding simple closure of an ulcer or vagotomy.
- •7.Current or historical evidence of any of the following diseases:
- •a.Zollinger-Ellison syndrome.
- •b.Primary oesophageal motility disorder(s) ie, achalasia, scleroderma, primary oesophageal spasm.
- •c.Malabsorption.
- •8.Significant cardiovascular, pulmonary, renal, pancreatic or liver disease as judged by the investigator to interfere with the evaluation of the study.
- •9.Unstable diabetes mellitus (stable diabetes controlled by diet, oral agents or insulin is not an exclusion criterion).
- •10.Cerebrovascular disease such as cerebral ischaemia, infarction, haemorrhage or embolus as judged by the investigator to interfere with the evaluation of the study.
- •11.Suspected or confirmed current malignancy, except minor superficial skin disease.
- •12.Use of any other investigational compound or participation in another clinical trial within the 90 days prior to start of study medication.
- •13.Need for continuous concomitant therapy with:
- •b.High dose steroids (more than 7.5 mg of prednisolone or its equivalent daily).
- •c.Cytotoxic drugs with the exception of methotrexate in patients with arthritis
- •14.Alcohol and/or drug abuse or any condition associated with poor compliance including expected non-cooperation, as judged by the investigator.
- •15.Previous participation in this study.
- •16.Contraindications to study drugs, e.g., known or suspected allergy to misoprostol
研究者
相似试验
已完成
3 期
Misoprostol for Small Bowel Ulcers and Obscure Bleeding Due to Aspirin or Nonsteroidal Antiinflammatory DrugsChronic ArthritisIschemic Heart DiseaseBleedingAtrial FibrillationAnemiaNCT02202967NHS Greater Glasgow and Clyde104
招募中
不适用
A clinical trial to study the efficacy of the drug misoprostol administered rectally in reducing excessive bleeding after normal deliveryCTRI/2014/08/004910DrSMCSIMedical college320
招募中
3 期
The effect of vaginal misoprostol and isosorbide mononitrate on under 20 week miscarriagesIRCT20190901044658N1Ardabil University of Medical Sciences120
已完成
不适用
Sublingual Misoprostol Versus Manual Vacuum Aspiration for Treatment of Incomplete Abortion in Nigeria: A Randomized Control StudyPregnancy and ChildbirthPACTR202009857889210212
已完成
不适用
Comparison of the effect of rectal Misoprostol and Syntometrin in prevention of post partum hemorrhagePost partum hemorrhage.Postpartum care and examinationIRCT201008212854N5Vice chancellor for Basic Sciences, Kashan University of Medical Sciences200