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: All

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) 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: 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 and throughout the entire study.
•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.

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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