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 - PYLHp07-01

• Conditions: Helicobacter Pylori infection; MedDRA version: 14.1Level: LLTClassification code 10051790Term: Helicobacter pylori gastritisSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2007-006280-78-IT
• Lead Sponsor: APTALIS PHARMA CANADA INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-19
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

maschi o femmine non incinte 18 anni e piu positivi per HP da C-13 UBT e almeno 2 da 3 test positivi tra rapid urease test,istologia e /o coltura
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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) no
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 (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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified