EUCTR2007-006280-78-PL进行中（未招募）不适用
Efficacy and Safety of Quadruple Therapy by Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Given x 10 days With Omeprazole in Eradication of Helicobacter pylori: A Comparison to Omeprazole, Amoxicillin and Clarithromycin Given x 7 days
Axcan Pharma Inc.0 个研究点目标入组 400 人开始时间: 2008年5月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
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
- •Male or non-pregnant, non-nursing female, 18 years of age and older
- •Women of childbearing potential must use a medically acceptable birth control method for the duration of the study and for 30 days thereafter. Women who are not of childbearing potential will be defined as post-menopausal (no presence of menses for at least 12 months) or surgically sterilized (tubal ligation for at least 6 months, ovariectomy or hysterectomy)
- •Positive for Helicobacter pylori by both C-13 UBT and at least two of three positive results among rapid urease test, histologic examination and/or culture
- •Presence of upper gastrointestinal symptoms
- •Mental and legal ability to give written informed consent
- •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
- •Previous surgery of the upper gastrointestinal tract (except appendectomy, polypectomy, or cholecystectomy)
- •Presence or history of clinically significant impairment of renal function, hepatic function, or liver disease
- •Presence or history of severe or unstable cardiovascular, pulmonary or endocrine disease
- •Presence or history of Zollinger Ellison Syndrome
- •Any current or recent (within 1 month of screening) hematemesis, melena, or documented gastrointestinal bleeding or iron-deficiency anaemia of clinical significance
- •Malignant disease of any kind except for successfully treated skin cancer (basal or squamous cell) during the previous 5 years
- •Barrett’s esophagus or high-grade dysplasia
- •Dysphagia or vomiting as major symptoms
- •Drug, alcohol or medication abuse within the past year
- •Continuous use of anti-ulcer drugs, including H2 receptor antagonists, sucralfate and prostaglandins during the 2 weeks preceding the C 13 UBT at screening
- •Continuous use of proton pump inhibitor in the 2 weeks preceding the C 13 UBT at screening
- •Chronic use of NSAIDs, except for acetyl-salicylic acid 100 mg or less daily
- •Requirement for anticoagulants (except for acetyl-salicylic acid 100 mg or less daily) and glucocorticoids (because of association with ulcer disease)
- •Use of antibiotics in the month before randomization
- •Regular use (> 3 times per week) of bismuth compounds in the month before randomization.
- •Presence of a contraindication to the use of metronidazole: e.g. active neurological disorder, history of blood dyscrasia, uncorrected hypothyroidism, uncorrected hypoadrenalism, or alcoholism, tetracycline (known sensitivity to tetracyclines), clarithromycin (known hypersensitivity to macrolides, use of cisapride, pimozide, terfenadine, astemizole and ergotamine/dihydroergotamine), amoxicillin (known sensitivity to penicilins), or omeprazole (known sensitivity to omeprazole).
- •Use of any experimental drug within the 30 days prior to randomization.
- •Previous attempt by a recognized antibiotic treatment to eradicate an adequately documented infection by Helicobacter pylori.
- •Known hypersensitivity to or previous adverse experience(s) with citric acid or any of the study drugs.
- •Patient known to be positive for HIV, hepatitis, or other diseases transmissible by blood or biopsy samples.
研究者
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Efficacy and Safety of Quadruple Therapy by Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Given x 10 days With Omeprazole in Eradication of Helicobacter pylori: A Comparison to Omeprazole, Amoxicillin and Clarithromycin Given x 7 daysMedDRA version: 9.1Level: HLTClassification code 10019375Term: Helicobacter infectionsHelicobacter pylori infectionEUCTR2007-006280-78-IEAxcan Pharma Inc.400
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Efficacy and Safety of Quadruple Therapy by Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Given x 10 days With Omeprazole in Eradication of Helicobacter pylori: A Comparison to Omeprazole, Amoxicillin and Clarithromycin Given x 7 daysHelicobacter pylori infectionEUCTR2007-006280-78-FRAxcan Pharma Inc.400
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Efficacy and Safety of Quadruple Therapy by Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Given x 10 days With Omeprazole in Eradication of Helicobacter pylori: A Comparison to Omeprazole, Amoxicillin and Clarithromycin Given x 7 daysMedDRA version: 9.1Level: HLTClassification code 10019375Term: Helicobacter infectionsHelicobacter pylori infectionEUCTR2007-006280-78-DEAxcan Pharma Inc.400