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

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 400

Inclusion Criteria

•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 if > 50 years of age, or no presence of menses for 24 months if = 50 years of age) 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 one of two positive results among histologic examination and culture, including PCR (Polymerase Chain Reaction).
•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

Exclusion Criteria

•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/platelet aggregation inhibitors except for cardiovascular disease prevention (for example acetyl-salicylic at a dose not exceeding 100 mg daily) and systemic glucocorticoids (because of association with ulcer disease)
•Use of systemic antibiotics in the month before screening
•Regular use (> 3 times per week) of bismuth compounds in the month before randomization.
•Presence of a contraindication to the use of metronidazole: active neurological disorder, history of blood dyscrasia, uncorrected hypothyroidism, uncorrected hypoadrenalism, alcoholism, concomitant use of disulfiram or use of disulfiram within the previous two weeks (can cause psychotic reactions), known hypersensitivity to metronidazole or any of its excipients; tetracycline: known hypersensitivity to tetracyclines or any of its excipients; clarithromycin: known hypersensitivity to macrolides or any of its excipients, use of cisapride, pimozide, terfenadine, astemizole, ergotamine/dihydroergotamine, use of colchicine (SmPC Section 4.4; colchicine toxicity reported, deaths in some such patients), use of HMG-CoA Reductase Inhibitors (SmPC Section 4.5; Rhabdomyolysis has been reported), use of quinidine or disopyramide (SmPC Section 4.5; post marketing reports of Torsade de Pointes); amoxicillin: hypersensitivity to penicillin or B lactam antibiotics (e.g. Cephalosporins) or any of its excipients, Glandular Fever (cause exanthema); omeprazole: known hypersensitivity to omeprazole or any of its excipients, patients with rare hereditary problems of galactose intolerance, Lapp Lactase deficiency, Glucose-Galactose malabsoption; bismuth: hypersensitivity to bismuth or any of its excipients; Maalox Plus®: hypersensitivity to Maalox or any of its excipients, patients with rare hereditary problems of fructose intolerance.

•Use of any experimental drug within the 30 days prior to randomization and throughout the entire study.
•Previous attempt by a recognized antibiotic treatment to eradicate an adequately documented infection by Helicobacter pylor

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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