EUCTR2004-002762-38-LT进行中（未招募）不适用
A randomised, double-blind, placebo-controlled study of AGI 001 in the treatment of functional dyspepsia
AGI Therapeutics Limited0 个研究点目标入组 125 人开始时间: 2005年2月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 125
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) Be aged 18-70 years
- •2) Have pain/discomfort centred in the upper abdomen, which may be characterised by or associated with upper abdominal fullness, early satiety, bloating, or nausea on a minimum of 8 days, which need not be consecutive within 8-14 days prior to the randomisation visit. A patient may be considered for randomisation at any time during the run-in period, provided they have had pain/discomfort centred in the upper abdomen on at least 8 days.
- •3) Fulfil Rome II criteria (modified) for functional dyspepsia i.e. in the last three months symptoms were present often (at least three weeks, at least one day a week) of:
- •a. Persistent or recurrent symptoms (pain or discomfort centred in the upper abdomen);
- •b. May be characterised by or associated with upper abdominal fullness, early satiety, bloating, or nausea; and
- •c. No evidence of organic disease (including at upper endoscopy) that is likely to explain the symptoms; and
- •d. No evidence that dyspepsia is exclusively relieved by defecation or associated with the onset of a change in stool frequency or stool form (i.e., not irritable bowel).
- •4) Provide signed written informed consent (Attachment 2).
- •5) Must be able to make entries into a touch tone telephone diary on a daily basis.
- •6) Must be willing to abstain from taking rescue medication in the run-in phase.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A potential participant may be excluded from the study if he/she:
- •1) Has gastroesophageal reflux disease:
- •a. Known heartburn as the predominant symptom and/or
- •b. Responds to proton pump inhibitors
- •2) Has H. pylori infection (can be enrolled if eradicated at least 3 months prior to enrolment and patient is negative for H. pylori at this time). The urea breath test or the CLO™ test will be used to test for H. pylori infection.
- •3) Has an identifiable cause, past or current for the symptoms, where if the disease improves or is eliminated, symptoms also improve. This will be assessed by endoscopy performed within 12 months prior to the randomisation visit, providing there has been no change in the patient’s symptoms during this period and will include: oesophageal, gastric or duodenal cancer, chronic peptic ulcer, oesophagitis (grade 2 or above), oesophageal ulceration or stricture or Barrett’s oesophagitis and evidence of prior oesophageal, gastric or duodenal surgery.
- •4) Presence or history of biliary tract disease, pancreatitis, colitis, inflammatory bowel disease, irritable bowel syndrome.
- •5) Requires immediate investigation, such as anaemia, unexplained weight loss, abdominal mass on abdominal examination, melaena, dysphagia, haematemesis or first presentation of symptoms in a patient over 50.
- •6) Has past or present disease likely to complicate the evaluation of the study treatment, e.g. significant cardiovascular, renal or liver disease, or malignancy.
- •7) Is pregnant or lactating. Women of childbearing potential must maintain effective contraception (See Section 5.4).
- •8) Uses drugs judged by the Investigator to be the cause of the current episode of dyspeptic symptoms.
- •9) Needs regular treatment with non-steroidal anti-inflammatory drugs within one month prior to commencing the study.
- •10) Uses daily continuous treatment with omeprazole or other proton pump inhibitors, H2-receptor antagonists, prokinetic agents, mucosal preparations, prostaglandin analogues, anticholinergics or drugs likely to alter 5-HT metabolism (e.g. 5-HT reuptake inhibitors, monoamine oxidase inhibitors), bismuth containing drugs within one month prior to commencing the study.
- •11) Has evidence of formal psychiatric illness, apart from depression (not major), which is controlled by antidepressants.
- •12) Has past or present alcohol or drug abuse in the opinion of the Investigator.
- •13) Has any evidence of cardiovascular disease or is taking any medication active on the cardiovascular system, apart from stable low dose (< 75 mg orally/day) aspirin as prophylaxis.
- •14) Has bronchial asthma
- •15) Has participated in any other clinical trial within the last month.
- •16) Has shown previous intolerance/sensitivity to the study medication.
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