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临床试验/ACTRN12607000287437
ACTRN12607000287437尚未招募4 期

An evaluation of the effect of Nexium Hp7 in patients with Helicobacter pylori and iron deficiency of obscure origin on the chance of persistent or recurrent iron deficiency after a course of oral iron therpay.

St Vincent's Health (Melbourne) Ltd0 个研究点目标入组 105 人开始时间: 2007年5月31日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
105

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 ot stated(—)
性别
Male

入选标准

  • Iron-deficiencyWilling to participate in studyAble to comply with requirements of study, including duration and blood testing.

排除标准

  • Unable to provide informed consentEndoscopies showing any of the following pathologies: Colonic carcinoma Gastric carcinoma Benign gastric or duodenal ulceration Multiple (>1) gastric erosions or haemorrhagic gastritis Multiple small, or at least one large (spider-like), angiodysplasia Gastric antral vascular ectasia Ampullary carcinoma Severe (grade 3 or higher) oesophagitis Previous gastrectomy Dieulafoy’s lesionHistory of, or duodenal biopsy showing, coeliac diseaseRequirement for blood transfusionCurrent overt gastrointestinal bleedingHistory of coagulation or platelet disorderHistory of receiving previous H.pylori eradication therapyAlready received iron therapy for more than 2 weeks for current episode of iron-deficiencyUnable to tolerate oral iron therapyPrevious drug reaction or allergic to any study drugPrevious drug reaction or allergic to any ingredient contained within Nexium Hp7Previous drug reaction or allergic to any proton pump inhibitorPrevious drug reaction or allergic to any penicillin, macrolide or cephalosporin antibioticCurrently taking cisapride, pimozide, ergotamine or dihydroergotamineCurrently taking anticoagulants (warfarin, heparin)History of taking non-steroidal anti-inflammatory drugs or clopidogrel within previous 3 monthsSevere liver diseaseElevated creatinine level > 120micromol/l or estimated glomerular filtration rate < 60ml/minKnown malignancy except localised skin cancerAny haemoglobinopathy or other haematological disorder apart from iron-deficiency anaemiaBlood donor at any time within previous six months.

研究者

发起方
St Vincent's Health (Melbourne) Ltd

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